JULY 2005
WEEK ENDING JULY 9
PRODUCT
a) Abilify (aripiprazole) 5 mg, 30 tablet bottles, Rx only,
NDC 59148-007-13.
b) Abilify (aripiprazole) 10 mg, 30 tablet bottles, Abilify
10 mg Tablets, blisters of 7 (samples), Rx only, NDC 59148-008-13
c) Abilify (aripiprazole) 15 mg, 30 tablet bottles, Rx
only, NDC 59148-009-13.
d) Abilify (aripiprazole) 30 mg, 30 tablet bottles, Rx
only, NDC 59148-011-13,
CODE
a) For 5mg. Lots 4B81979 , 4C83077, 4C92612;
b) For 10mg. Lots 3L69888, 3L69889, 4B81980 - 30
tablet/bottle For 10 mg - 7 tablet blister;
c) For 15mg. Lots 3L69891, 3L69892, 3L69899;
d) For 30 mg. Lot 4B79310
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bristol-Myers Squibb Company, New Brunswick, NJ
Manufacturer: Bristol-Myers Squibb Manufacturing Company,
Mayaguez, PR.
REASON
Dissolution Failure
VOLUME OF PRODUCT IN COMMERCE
566,,836 bottles and 300,280 blisters
DISTRIBUTION
Nationwide
PRODUCT
Benazepril Hydrochloride Tablets, 40 mg, 100 count bottles, Rx only, NDC
0185-0048-05
CODE
Lot #W030655, Expiration 08/05
RECALLING FIRM/MANUFACTURER
Recalling Firm: Eon Pharma Lle, Wilson, NC
Manufacturer: Eon Labs, Inc, Laurelton, NY.
REASON
Dissolution failure at 18 month stability.
VOLUME OF PRODUCT IN COMMERCE
9577 bottles (100 tablets per bottle)
DISTRIBUTION
Nationwide
PRODUCT
Hydrocortisone Acetate Suppositories, 25 mg, NDC 53265-761-12, (12 packs) and NDC 53265-761-24(24 packs),
CODE
All codes being recalled
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc., Cranbury, NJ
Manufacturer: Able Laboratories, Inc., South Plainfield, NJ.
REASON
There is lack of assurance that testing conducted for release and stability conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
32 lots
DISTRIBUTION
Nationwide
PRODUCT
a) Eyedrops, Extra Relief, Naphazoline hydrochloide 0.012%,
Glycerine 1.2%, 20mL, NDC 67234-010-01,
b) Eyedrops, Seasonal Relief, Naphazoline hydrochloide
0.012%, Glycerine 1.2%, Zinc Sulfate, 0.25%, 20mL, NDC 67234-011-01,
c) Eyedrops, Artifical Tears, Polyvinyl alcohol 0.5%, Povidone, 0.6%, 20mL, NDC 67234-009-01
CODE
a) Lot Numbers: 1235, 1045, 0915
b) Lot Numbers: 1185, 0835
c) Lot Number: 1105
RECALLING FIRM/MANUFACTURER
Natureplex LLC, Memphis, TN
REASON
Lack of assurance of sterility
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide
PRODUCT
Size E medical gas cylinders containing Compressed Gas, N.O.S. UN3156 Oxygen-Carbon Dioxide
gas
CODE
Lot # 1022BG04
RECALLING FIRM/MANUFACTURER
Specialty Gases of America Inc, Toledo, OH
REASON
Incorrect CGA valve used.
VOLUME OF PRODUCT IN COMMERCE
12 size E medical gas cylinders
DISTRIBUTION
MI
PRODUCT
a) Atenolol Tablets, USP 25 mg, NDC 53265-412-10,
NDC 53265-412-11, (100s and 1000s)
b) Atenolol Tablets, USP 50 mg, NDC 53265-413-10,and
NDC 53265-413-11, (100s and 1000s)
c) Atenolol Tablets, USP 100 mg, NDC 53265-414-10,and
NDC 53265-414-11, (100s and 1000s)
CODE
All lots are being recalled
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc., Cranbury, NJ
Manufacturer: Able Laboratories, Inc., South Plainfield, NJ.
REASON
There is a lack of assurance that testing conducted for release and stability conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
68 lots
DISTRIBUTION
Nationwide
PRODUCT
a) Hydrocodone Bitartrate and Acetaminophen Tablets, USP,
5 mg/325 mg CIII, NDC 53265-345-10,and NDC 53265-345-50,
(100s and 500s)
b) Hydrocodone Bitartrate and Acetaminophen Tablets, USP,
5 mg/500 mg CIII, NDC 53265-329-10,and NDC 53265-329-50,
(100s and 500s)
c) Hydrocodone Bitartrate and Acetaminophen Tablets, USP,
7.5 mg/325 mg CIII, NDC 53265-335-10,and NDC 53265-335-
50, (100s and 500s)
d) Hydrocodone Bitartrate and Acetaminophen Tablets, USP,
7.5 mg/500 mg CIII, NDC 53265-330-10,and NDC 53265-330-
50, (100s and 500s)
e) Hydrocodone Bitartrate and Acetaminophen Tablets, USP,
7.5 mg/650 mg CIII, NDC 53265-332-10,and NDC 53265-332-
50, (100s and 500s)
f) Hydrocodone Bitartrate and Acetaminophen Tablets, USP,
10 mg/325 mg CIII, NDC 53265-328-10,and NDC 53265-328-
50, (100s and 500s)
g) Hydrocodone Bitartrate and Acetaminophen Tablets, USP,
10 mg/500 mg CIII, NDC 53265-331-10,and NDC 53265-331-
50, (100s and 500s)
h) Hydrocodone Bitartrate and Acetaminophen Tablets, USP,
10 mg/650 mg CIII, NDC 53265-333-10,and NDC 53265-333-
50, (100s and 500s)
i) Hydrocodone Bitartrate and Acetaminophen Tablets, USP,
7.5 mg/57.0 mg CIII, NDC 53265-334-10,and NDC 53265-334-
50, (100s and 500s)
CODE
All codes are being recalled.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc., Cranbury, NJ.
Manufacturer: Able Laboratories, Inc., South Plainfield, NJ.
REASON
There is a lack of assurance that testing conducted for release and stability conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
149 lots
DISTRIBUTION
Nationwide
PRODUCT
a) Acetaminophen & Codeine Phosphate Tablets, USP,
300 mg/30mg CIII, NDC 53265-285-10, NDC 53265-285-11,
NDC 53265-285-50, (100s, 500s and 1000s),
b) Acetaminophen & Codeine Phosphate Tablets, USP,
300 mg/60mg CIII, NDC 53265-286-10, NDC 53265-286-50,
NDC 53265-286-11, (100s, 500s and 1000s),
CODE
All lots are being recalled
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc., Cranbury, NJ
Manufacturer: Able Laboratories, Inc., South Plainfield, NJ.
REASON
There is a lack of assurance that testing conducted for release and stability conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
64 lots
DISTRIBUTION
Nationwide
PRODUCT
a) Clorazepate Dipotassium Tablets, USP, 3.75 mg, CIV,
NDC 53265-048-10, (100s)
b) Clorazepate Dipotassium Tablets, USP, 7.5 mg, CIV,
NDC 53265-049-10, and NDC 53265-049-50, (100s and 500s),
c) Clorazepate Dipotassium Tablets, USP, 15 mg, CIV,
NDC 53265-050-10, (100s)
CODE
All lots are being recalled
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc., Cranbury, NJ
Manufacturer: Able Laboratories, Inc., South Plainfield, NJ.
REASON
There is a lack of assurance that testing conducted for release and stability conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
30 lots
DISTRIBUTION
Nationwide
PRODUCT Vivelle-Dot, Transdermal System, (estradiol) 0.1 mg, 8 systems per carton (retail), 2 units per carton (physician samples).
CODE
Batch #/Expiry: 76061011, May 05; 76991011, May 05; 74961021, May 05; 74961012, May 05; (Physician samples) 74961022, May 05; (Physician samples) 76981011, May 05; 79151011, Jun 05; 79151012, Jun 05 (Physician samples) 79751011, Jun 05; 80251011, Jun 05.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Novartis Pharmaceuticals, Corp, East Hanover, NY
Manufacturer: Noven Pharmaceuticals, Miami, FL.
REASON
Stability Failure
VOLUME OF PRODUCT IN COMMERCE
340,726 units
DISTRIBUTION
Nationwide
PRODUCT
a) PREMARIN (conjugated estrogens USP),0.45 mg, 100-tablet
bottles, Rx, NDC 0046-0936-81.
b) PREMARIN (conjugated estrogens USP), 1.25 mg, Rx. 100-
tablet bottles- NDC 0046-0866-81. 1000-tablet bottles -
NDC 0046-0866-91.
CODE
a) A52584, Exp. 6/2005 and A84755, Exp. 3/2006;
b) 100 tablet bottles: A36363 Exp. 7/2005; A77945 Exp.
10/2006; 1000 tablet bottles: A34501 Exp. 7/2005; A52586
Exp. 7/2005
RECALLING FIRM/MANUFACTURER
Recalling Firm: Richmond Division of Wyeth Pharmaceuticals, Richmond,
VA
Manufacturer: Wyeth Pharmaceuticals, Rouses Point, NY.
REASON
Dissolution Failure
VOLUME OF PRODUCT IN COMMERCE
173,870 - 0.45/100's; 50,636 - 1.25/100's; 18,492 - 1.25/1000's
DISTRIBUTION
Nationwide
PRODUCT
a) Estraderm® (estradiol transdermal system) 0.05 mg/day,
Rx only. 8 individual sealed patches/systems per patient
calendar pack, 6 patient calendar packs per pharmacy
shelf box. Each patient calendar pack of 8 systems is a
1-month supply. Pharmacy shelf box of 6 patient calendar
packs/8 systems each - NDC # 0083-2310-62, patient
calendar packs of 8 systems - NDC # 0083-2310-08,
individual transdermal pouch (system) - NDC # 0083-2310-
01 --- Transdermal pouch labeling in part: NDC 0083-
2310-01, NOVARTIS, 0.05, ESTRADERM® estradiol
transdermal system, Delivers 0.05 mg/day, Rx only.
Patient calendar pack labeling in part: NDC 0083-2310-
08, NOVARTIS, ESTRADERM® estradiol transdermal system,
Delivers 0.05 mg/day, Rx only, 0.05. Pharmacy shelf box
labeling in part: NDC 0083-2310-62, 0.05, Estraderm®
estradiol transdermal system, Delivers 0.05 mg/day, Rx
only, TRANSDERMAL USE ONLY. Contents: 6 patient calendar
packs of 8 systems each.
b) Estraderm® (estradiol transdermal system) 0.1 mg/day, Rx
only. 8 individual sealed patches/systems per patient
calendar pack, 6 patient calendar packs per pharmacy
shelf box. Each patient calendar pack of 8 systems is a
1 month supply. Pharmacy shelf box of 6 patient calendar
packs/8 systems - NDC # 0083-2320-62, patient calendar
packs of 8 systems - NDC # 0083-2320-08, individual
pouch (system) - NDC # 0083-2320-01 --- Transdermal
pouch labeling in part: NDC 0083-2320-01, NOVARTIS, 0.1,
ESTRADERM® estradiol transdermal system, Delivers 0.1
mg/day, Rx only. Patient calendar pack labeling in part:
NDC 0083-2320-08, NOVARTIS, ESTRADERM® estradiol
transdermal system, Delivers 0.1 mg/day, Rx only, 0.1.
Pharmacy shelf box labeling in part: NDC 0083-2320-62,
0.1, Estraderm® estradiol transdermal system, Delivers
mg/day, Rx only, TRANSDERMAL USE ONLY. Contents: 6
patient calendar packs of 8 systems each.
CODE
a) Estraderm® 0.05 mg lot numbers: F0003 (exp. 2/28/06),
F0004 (exp. 3/31/06), F0005 (exp. 4/30/06), F0006 (exp.
5/31/06), F0007 (exp. 6/30/06), F0009 (exp. 6/30/06).
b) Estraderm® 0.1 mg lot numbers: F4066 (exp. 3/31/06),
F4067 (exp. 4/30/06), F4068 (exp. 4/30/06), F4069 (exp. 6/30/06), F4070 (exp. 7/31/06). Pharmacy shelf box of 6 patient calendar packs of 8 systems: NDC 0083-2320-62; patient calendar packs of 8 systems: NDC 0083-2320-08; individual system pouch: NDC 0083-2320-01.
RECALLING FIRM/MANUFACTURER
Novartis Pharmaceuticals, Corp, Suffern, NY
REASON
Labeling: the patient booklet contained in each patient calendar pack of 8 systems does not include the required current black box warning for estrogens as contained in the approved NDA labeling (the black box warning was updated in August 2004).
VOLUME OF PRODUCT IN COMMERCE
514,026 patient calendar packs containing 8 systems each (85,671 pharmacy shelf boxes) for all 11 lots
DISTRIBUTION
Nationwide & PR
WEEK ENDING JULY 16
PRODUCT
a) Bethanechol Chloride Tablets, USP 5mg. NDC 53265-339-10, (100s)
b) Bethanechol Chloride Tablets, USP, 10mg. NDC 53265-340-
10, (100s)
c) Bethanechol Chloride Tablets, USP, 25mg. NDC 53265-338-
10, (100s)
d) Bethanechol Chloride Tablets, USP, 50mg. NDC 53265-341-
10, (100s)
CODE
All Lots bring recalled
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury, NJ
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ.
REASON
There is a lack of assurance that testing conducted for release and stability
conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
13 lots
DISTRIBUTION
Nationwide
PRODUCT
a) Butalbital, Acetaminophen and Caffeine Tablets, USP,
50mg/325mg/40mg, NDC 53265-236-10 and NDC 53265-236-50,
(100s and 500s)
b) Butalbital, Acetaminophen and Caffeine Tablets, USP,
50mg/500mg/40mg, NDC 53265-235-10 and NDC 53265-235-50,
(100s and 500s)
CODE
All lots are bring recalled
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury, NJ
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ.
REASON
There is a lack of assurance that testing conducted for release and stability
conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
181 lots
DISTRIBUTION
Nationwide
PRODUCT
a) Indomethacin Capsules, USP, 25 mg, NDC 53265-267-10 and
NDC 53265-267-11 (100s and 1000s), Green,
b) Indomethacin Capsules, USP, 50 mg, NDC 53265-268-10 and
NDC 53265-268-50, (100s and 500s), Green,
c) Indomethacin Extended-Release Capsules, USP 75 mg, NDC
53265-269-60 and NDC 53265-269-10 (60s and 100s),
Yellow/Clear
CODE
All lots are being recalled
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury, NJ
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ.
REASON
There is a lack of assurance that testing conducted for release and stability
conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
38 lots
DISTRIBUTION
Nationwide
PRODUCT
a) Naproxen Sodium Tablets, USP, 275mg. NDC 53265-363-10
and NDC 53265-363-50 (100s and 500s).
b) Naproxen Sodium Tablets, USP. 550mg. NDC 53265-364-10
and NDC 53265-364-50. (100s and 500s).
CODE
All codes are being recalled
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury, NJ
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ.
REASON
There is a lack of assurance that testing conducted for release and stability
conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
20 lots
DISTRIBUTION
Nationwide
PRODUCT
Methamphetamine Hydrochloride Tablets, USP CII, 5 mg, NDC 53265-396-10
(100s)
CODE
All lots are being recalled
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury, NJ
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ.
REASON
There is a lack of assurance that testing conducted for release and stability
conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
6 lots
DISTRIBUTION
Nationwide
PRODUCT
a) Methocarbamol Tablets, USP, 500mg, NDC 53265-265-10 and
NDC 53265-265-50 (100s and 500s),
b) Methocarbamol Tablets, USP, 750mg, NDC 53265-264-10 and
NDC 53265-264-50 (100s and 500s)
CODE
All codes are being recalled
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury, NJ.
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ.
REASON
There is a lack of assurance that testing conducted for release and stability
conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
19 lots
DISTRIBUTION
Nationwide
PRODUCT
a) Lithium Carbonate Capsules, USP, 150mg. NDC 53265-355-
10 and NDC 53265-355-50. (100s and 500s),
b) Lithium Carbonate Capsules, USP, 600mg. NDC 53265-355-
10 (100s)
c) Lithium Carbonate Capsules, USP, 300mg. NDC 53265-270-
10 and NDC 53265-270-11. (100s and 1000s), Pink.
d) Lithium Carbonate Extended-Release Tablets, USP, 300mg.
NDC 53265-283-10. (100s)
CODE
All codes are being recalled
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury, NJ.
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ.
REASON
There is a lack of assurance that testing conducted for release and stability
conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
505 lots
DISTRIBUTION
Nationwide
PRODUCT
Diphenoxylate Hyrdochloride and Atropine Sulfate Tablets, USP 2.5mg/0.025mg,
CV, NDC 53265-237-10, NDC 53265-237-50, and NDC 53265-237-11. (100s, 500s,
1000s)
CODE
All lots are being recalled
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury, NJ
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ.
REASON
There is a lack of assurance that testing conducted for release and stability
conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
38 lots
DISTRIBUTION
Nationwide
PRODUCT
a) Hydrocodone Bitartrate and Acetaminophen Tablets, USP,
5 mg/500 mg C-III; an Rx oral schedule C-III narcotic
analgesic and antitussive; single tablet unit dose
packs, NDC #51079-420-20: 10 sheets of 10 unit dose
tablets, NDC #51079-420-21: 5 sheets of 20 unit dose
tablets, NDC #51079-420-99: 15 sheets of 6 unit dose tablets
b) Lithium Carbonate Capsules, USP, 300 mg; an Rx oral
antimanic medication; single capsule unit dose blister
packs, 10 sheets of 10 unit dose capsules per carton;
NDC #51079-269-20
c) Promethazine Hydrochloride Tablets, USP, 25 mg; an oral
antihistamine/sedative/antiemetic; single tablet unit
dose blister packs, 10 sheets of 10 unit dose tablets
per carton; NDC # 51079-895-20
d) Lithium Carbonate Extended-Release Tablets, USP, 300 mg;
an Rx oral antimanic medication; single tablet unit dose
blister packs, 10 sheets of 10 unit dose tablets per
carton; NDC #51079-253-20
e) Hydrocodone Bitartrate and Acetaminophen Tablets, USP,
7.5 mg/ 500 mg C-III; an Rx oral schedule C-III narcotic
analgesic and antitussive; single tablet unit dose
blister packs, 5 sheets of 20 unit dose tablets per
carton; NDC #51079-867-21,
f) Hydrocodone Bitartrate and Acetaminophen Tablets, USP,
7.5 mg/750 mg C-III; an Rx oral schedule C-III narcotic
analgesic and antitussive; single tablet unit dose
blister packs, 5 sheets of 20 unit dose tablets per
carton; NDC # 51079-748-21,
g) Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5
mg/325 mg C-III; an Rx oral schedule C-III narcotic
analgesic and antitussive; single tablet unit dose
blister packs, 5 sheets of 20 unit dose tablets per
carton; NDC # 51079-274-21,
h) Hydrocodone Bitartrate and Acetaminophen Tablets, USP,
7.5 mg/325 mg C-III; an Rx oral schedule C-III narcotic
analgesic and antitussive; single tablet unit dose
blister packs, 5 sheets of 20 unit dose tablets per
carton; NDC # 51079-295-21,
i) Hydrocodone Bitartrate and Acetaminophen Tablets,
USP,
10 mg/325 mg, C-III; an Rx oral schedule C-III narcotic analgesic and
antitussive;
single tablet unit dose blister packs, 5 sheets of 20 unit dose tablets per
carton; NDC # 51079-305-21
CODE
a) NDC # 51079-420-20: lots 4C904, 4D247, 4D265, 4F055,
4H100, 4J390, 4J450, 4M601, 4M643, 4P837, 4V011, 4V077,
5B231, 5B304, 5C449. NDC #51079-420-21: lots 4D319,
4F044, 4J381, 4K531, 4S859, 4S958, 5A116, 5B306. NDC#
51079-420-99: lots 4D321, 4J340, 4J375, 4J441, 4K538,
4M669, 4P762, 4S869, 4V063, 4V984, 5B220, 5C339, 5F533;
b) Lot 4S867;
c) Lot 5C500;
d) Lots 4M695, 4V059, 4V996;
e) Lots 4D258, 4K516, 4P804, 4H111, 4V024, 5C390;
f) Lots 4H091, 4M650, 4V990, 5C474;
g) Lot 4V037;
h) Lot 4V978;
i) Lot 4V040
RECALLING FIRM/MANUFACTURER
Recalling Firm: UDL Laboratories, Inc., Rockford, IL.
Manufacturer: Able Laboratories, Inc., South Plainfield, NJ.
REASON
The drug products repackaged by UDL were recalled by the manufacturer, Able
Laboratories due to a lack of assurance that testing conducted for release
and stability conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
284,703 cartons of 100 u/d and 21,186 cartons of 90 u/d
DISTRIBUTION
Nationwide
PRODUCT
a) Hydroxyzine Hyrdochloride Tablets, USP 10mg, NDC 53265-
387-10, NDC 53265-387-50, and NDC 53265-387-11. (100s,
500s, 1000s)
b) Hydroxyzine Hyrdochloride Tablets, USP 25mg, NDC 53265-
388-10, NDC 53265-388-50, and NDC 53265-388-11. (100s,
500s, 1000s)
c) Hydroxyzine Hyrdochloride Tablets, USP 50mg, NDC 53265-
389-10, NDC 53265-389-50, and NDC 53265-389-11. (100s,
500s, 1000s)
CODE
All lots are being recalled
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury, NJ.
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ. .
REASON
There is a lack of assurance that testing conducted for release and stability
conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
23 lots
DISTRIBUTION
Nationwide
PRODUCT
a) Salsalate Tablets, USP 500mg, NDC 53265-132-10 and
NDC 53265-132-50, (100s and 500s)
b) Salsalate Tablets, USP 750mg, NDC 53265-133-10 and
NDC 53265-133-50, (100s and 500s)
CODE
All lots are being recalled
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury, NJ
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ.
REASON
There is a lack of assurance that testing conducted for release and stability
conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
48 lots
DISTRIBUTION
Nationwide
PRODUCT
Carisoprodol Tablets, USP 350mg, NDC 53265-266-10, NDC 53265-266-50 and NDC
53265-266-11, (100s and 500s, 1000s)
CODE
All lots are being recalled
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury, NJ.
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ.
REASON
There is a lack of assurance that testing conducted for release and stability
conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
335 lots
DISTRIBUTION
Nationwide
PRODUCT
a) Propoxyphene Napsylate and Acetaminophen Tablets, USP,
100mg/650mg (Pink) CIV. NDC 53265-256-10, NDC 53265-256-
50 and NDC 53265-256-11. (100s, 500s and 1000s)).
b) Propoxyphene Napsylate and Acetaminophen Tablets, USP,
100mg/650mg (White) CIV. NDC 53265-261-10, NDC 53265-
261-11 and NDC 53265-261-50. (100s, 500s and 1000s),
CODE
All lots are being recalled
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury, NJ.
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ.
REASON
There is a lack of assurance that testing conducted for release and stability
conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
526 lots
DISTRIBUTION
Nationwide
PRODUCT
a) Phentermine HCl Capsules, USP, 15 mg, CIV,
NDC 53265-346-10 and NDC 53265-346-11 (100s and 1000s),
Grey/Yellow,
b) Phentermine HCl Tablets, USP, 37.5 mg, CIV, NDC 53265-
257-10 and NDC 53265-257-11. (100s and 1000s),
c) Phentermine HCl Capsules, USP, 30 mg CIV, NDC 53265-258-
10 and NDC 53265-258-11 (100s and 1000s). Yellow/Yellow,
d) Phentermine HCl Capsules, USP, 30 mg BEADS, NDC 53265-
259-10 and NDC 53265-259-11, (100s and 1000s),
blue/clear, CIV
CODE
All lots are being recalled
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury, NJ
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ.
REASON
There is a lack of assurance that testing conducted for release and stability
conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
208 lots
DISTRIBUTION
Nationwide
PRODUCT
a) Ciprofloxacin Tablets, USP, 250 mg. 100-tablet bottles,
NDC 52555-769-01
b) Ciprofloxacin Tablets, USP, 500 mg., 100-tablet bottles,
NDC 52555-770-01
c) Ciprofloxacin Tablets, USP, 750 mg., 50-tablet bottles,
NDC 52555-771-50.
CODE
a) Lot number B040015, Exp. April, 2006;
b) Lot numbers B040017 Exp. April 2006, B040018 Exp. April
2006, B040019 Exp. April 2006, B040020 Exp. April 2006,
B040021 Exp. April 2006, B040075 Exp. August 2006,
B040081 Exp. August 2006, B040082 Exp. August 2006, and
B040120 Exp. October 2006, B050012 Exp. January 2007,
and B050022 Exp. January 2007;
c) Lot number B040016, Exp. April 2006
RECALLING FIRM/MANUFACTURER
Martec Scientific, Inc., Kansas City, MO,
REASON
Method validation deviations for finished product testing and inadequate
Out of Specification (OOS) investigations for Blend Uniformity testing.
VOLUME OF PRODUCT IN COMMERCE
8,289/100/250-mg. tablet bottles; 45,996/100/500-mg. tablet bottles; and
6,290/50/750-mg. tablet bottles.
DISTRIBUTION
Nationwide
PRODUCT
Vinorelbine Tartrate Injection, 10mg/mL, 1 and 5 mL vials, For Intravenous
Use Only, Rx only, NDC 10019-970-02 ---- Also under other brand as Vinorelbine
Tartrate Injection, 10mg/mL, ESI Lederle, Philadelphia, PA,
CODE
1mL lots: 601248 exp 7/05; 601416 exp 11/05; A71275 exp 6/06; A93267 exp
8/06. 5mL lots: 601216 exp 7/05; 601217 exp 7/05; 601218 exp 7/05; 601219
exp 7/05; 601412 exp 8/05; A71276 exp 3/06; A71277 exp 3/06; A71278 exp 4/06
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Anesthesia and Critical Care, New Providence,
NJ
Manufacturer: Wyeth Parenterals Divison of Wyeth Holdings Corp. Carolina,
PR.
REASON
Exceeds Impurity Level
VOLUME OF PRODUCT IN COMMERCE
1 mL = 54202 vials; 5 mL = 33055 vials
DISTRIBUTION
Nationwide
WEEK ENDING JULY 23
PRODUCT
a) MAGNESIUM
SULFATE 1 g (2 ml of 50% Injection) added to 50 ml 5% Dextrose Injection USP
Qty. 24 C.O.M.P.A.S.S.
NDC # 61553-410-41
b) MAGNESIUM
SULFATE 2 g (4 ml of 50% Injection) added to 50 ml 5% Dextrose Injection USP
C.O.M.P.A.S.S. NDC #
61553-411-41
c) MAGNESIUM SULFATE
4 g (8 ml of 50% Injection) added to 50 ml 5% Dextrose Injection USP
C.O.M.P.A.S.S. NDC #
61553-412-41
d) MAGNESIUM SULFATE
6 g (12 ml of 50% Injection) added to 50 ml 5% Dextrose Injection USP
C.O.M.P.A.S.S. NDC #
61553-413-41
e) MAGNESIUM SULFATE
3 g (6 ml of 50% Injection) added to 50 ml 5% Dextrose Injection USP
C.O.M.P.A.S.S. NDC #
61553-419-41
CODE
a) Service Code: 2K2410, all lots remaining
in expiry life;
b) Service Code: 2K2411, all lots remaining in expiry
life;
c) Service Code: 2K2412, all lots remaining in expiry life;
d)
Service Code: 2K2413, all lots remaining in expiry life;
e) Service Code:
2K2419, all lots remaining in expiry life
RECALLING
FIRM/MANUFACTURER
Recalling Firm: PharMedium Services, LLc, Lake
Forest, IL
Manufacturer: PharMedium Services, LLc, Houston, TX.
REASON
Bacterial contamination of an
injectable product, product not labeled as sterile.
VOLUME OF PRODUCT
IN COMMERCE 116,328 units
DISTRIBUTION Nationwide
PRODUCT
a)
Metronidazole Tablets, USP, 250 mg, NDC #53265-374-10, NDC # 53265-374-70,
and NDC # 53265-374-50, (100s, 250s, 500s)
b)
Metronidazole Tablets, USP, 500 mg, NDC #53265-375-60, NDC # 53265-375-10,
and NDC # 53265-375-50, (60s, 100s,
500s)
c)
Metronidazole Capsules, 375 mg, NDC #53265-353-05, (50s,)
d) Metronidazole Extended-Release Tablets, 750 mg, NDC # 53265-352-03, (30s)
CODE
All lots being
recalled.
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Able Laboratories, Inc, Cranbury, NJ
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ.
REASON
There is a lack of
assurance that testing for release and stability conformed to standard operating
procedures.
VOLUME OF PRODUCT IN COMMERCE 54
lots
DISTRIBUTION Nationwide
PRODUCT
a)
Nitroglycerin Tablets, USP, 0.3 mg, NDC # 53265-249-10(100s)
b) Nitroglycerin Tablets, USP, 0.4 mg, NDC # 53265-250-04
and
NDC # 53265-250-10. (25s and 100s)
c) Nitroglycerin
Tablets, USP, 0.6 mg, NDC # 53265-251-10 (100s)
CODE All lots being
recalled.
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Able Laboratories, Inc, Cranbury, NJ
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ.
REASON
There is a lack of
assurance that testing for release and stability conformed to standard operating
procedures.
VOLUME OF PRODUCT IN COMMERCE 310
lots
DISTRIBUTION Nationwide
PRODUCT Tramadol
Hydrochloride Tablets, 50 mg, NDC # 0172-6515-60, NDC # 0172-6515-70 and NDC #
0172-6515-10 (100s, 500s and 100 count unit dose tablets)
CODE
All codes being
recalled.
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Able Laboratories, Inc, Cranbury, NJ
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ.
REASON
There is a lack of
assurance that testing for release and stability conformed to standard operating
procedures.
VOLUME OF PRODUCT IN COMMERCE 49
lots
DISTRIBUTION FL
PRODUCT
a)
Theophylline Extended-Release Tablets, 400 mg, NDC # 53265-380-10, NDC #
53265-380-50. (100s and 500s),
b) Theophylline
Extended-Release Tablets, 600 mg, NDC # 53265-382-10, (100s),
CODE
All codes being
recalled.
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Able Laboratories, Inc, Cranbury, NJ,
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ.
REASON
There is a lack of
assurance that testing for release and stability conformed to standard operating
procedures.
VOLUME OF PRODUCT IN COMMERCE 22
lots
DISTRIBUTION Nationwide
PRODUCT Butalbital,
Acetaminophen, Caffeine and Codeine Phosphate Capsules, (CIII), 50 mg/325 mg/40
mg/30 mg, NDC # 53265-240-10, (100s),
CODE All codes being recalled.
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury,
NJ
Manufacturer: Able
Laboratories, Inc, South Plainfield, NJ.
REASON There is a lack of assurance that testing for
release and stability conformed to standard operating
procedures.
VOLUME OF PRODUCT IN COMMERCE 6
lots
DISTRIBUTION Nationwide
PRODUCT
a)
Prochlorperazine Suppository, USP, 2.5 mg, NDC # 53265-243-12, 12
Pediatric-Size Suppositories
b) Prochlorperazine
Suppository, USP, 5 mg, NDC # 53265-244-12, 12 suppositories for older Children (not under 40 lbs.),
c) Prochlorperazine
Suppository, USP, 25 mg, NDC # 53265-245-12, 12 Adult Suppositories. Note: Not for Use in Children,
CODE All
codes being recalled.
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury,
NJ,
Manufacturer: Able
Laboratories, Inc, South Plainfield, NJ.
REASON There is a lack of assurance that testing for
release and stability conformed to standard operating
procedures.
VOLUME OF PRODUCT IN COMMERCE 16
lots
DISTRIBUTION Nationwide
PRODUCT
a)
Promethazine Hydrochloride Suppository, USP, 12.5 mg, 12 Rectal
Suppositories, For Rectal Use Only,
Rx only, NDC # 53265-762-12,
b) Promethazine Hydrochloride Suppository, USP, 25 mg,
12 Rectal
Suppositories, For Rectal Use Only, Rx only,
NDC # 53265-763-12,
c) Promethazine Hydrochloride Suppository, USP, 50 mg,
12 Rectal
Suppositories, For Rectal Use Only, Rx only,
NDC # 53265-764-12,
d) Promethazine Hydrochloride Tablets, USP, 12.5 mg,
100 count
bottles, Rx only, NDC # 53265-405-10,
e) Promethazine
Hydrochloride Tablets, USP, 25 mg, 100 and 1000 count bottles, Rx only, NDC
# 53265-406-10
and NDC 53265-406-11,
f) Promethazine
Hydrochloride Tablets, USP, 50 mg, 100 count bottles, Rx only, NDC #
53265-405-10,
CODE All lots being
recalled.
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Able Laboratories, Inc, Cranbury, NJ,
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ.
REASON
There is a lack of
assurance that testing for release and stability conformed to standard operating
procedures.
VOLUME OF PRODUCT IN COMMERCE 159
lots
DISTRIBUTION Nationwide
PRODUCT Children’s
Tylenol Soft-Chews Fruit Flavor, 80 mg, 60 and 96 counts blister, OTC
CODE
All lots
RECALLING
FIRM/MANUFACTURER
Recalling Firm: McNeil Consumer & Specialty
Pharmaceuticals, Fort Washington, PA,
Manufacturer: McNeil Consumer and Specialty Pharmaceuticals, Las
Piedras, PR.
REASON The
blister package design, as well as the information on the blisterpackage and on
the blister and bottle cartons may be confusing and could lead to improper
dosing, including over-dosing.
VOLUME OF PRODUCT IN
COMMERCE 185,472 units
DISTRIBUTION Nationwide
PRODUCT
a)
Phenazopridine HCl Tablets, USP 100 mg, 100 and 1000 count bottles, Rx Only, NDC # 53265-196-10, and 53265-196-11, Also
Labeled as Pyridium Tablets
100 mg, Pfizer, Inc,
b) Phenazopridine HCl Tablets, USP
95 mg, (Bulk),
c) Phenazopridine HCl Tablets, USP 200
mg, 100 and 1000 count bottles, NDC # 53265-197-10, and 53265-197-11,
Also Labeled as Pyridium Tablets 200 mg, Pfizer, Inc,
CODE All codes being recalled.
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury,
NJ,
Manufacturer: Able Laboratories, Inc, South
Plainfield, NJ.
REASON There is a lack of assurance that testing for
release and stability conformed to standard operating
procedures.
VOLUME OF PRODUCT IN COMMERCE 108
lots
DISTRIBUTION Nationwide. The product was shipped in
bulk to Pfizer, Inc, NY, NY for distribution under their label to Canada, South
America and
Indonesia.
PRODUCT
a)
Jr. Tylenol Meltaways Bubblegum Burst, 160 mg, 24 counts blister, OTC,
b) Children’s Tylenol Meltaways Bubblegum Burst
Flavor,
80 mg, 48 and 64 counts blister, OTC,
c) Jr. Tylenol
Meltaways Grape, 160 mg, 24 and 48 counts blister, OTC,
d) Children’s Tylenol Meltaways Bubblegum Burst
Flavor, 80 mg,
30 counts bottles, OTC,
e) Children’s Tylenol Meltaways
Watermelon Flavor,80 mg, 30 counts bottles, OTC,
f)
Children’s Tylenol Meltaways Grape Flavor, 80 mg, 30 counts bottles, OTC,
CODE
All lots
RECALLING
FIRM/MANUFACTURER
Recalling Firm: McNeil Consumer & Specialty
Pharmaceuticals, Fort Washington, PA,
Manufacturer: McNeil Consumer and Specialty Pharmaceuticals, Las
Piedras, PR.
REASON The
blister package design, as well as the information on the blister package and on
the blister and bottle cartons may be confusing and could lead to improper
dosing, including over-dosing.
VOLUME OF PRODUCT IN
COMMERCE 10,485,008
DISTRIBUTION MS, PS,
USVI, CA, Bermuda, Guam and
Cayman
PRODUCT
a)
Andehist NR Syrup, Antihistamine/Decongestant, Brompheniramine Maleate 4 mg,
Pseudoephedrine Hydrochloride,
45 mg, NDC # 60258-434-16, 16 fl. oz.
b) Andehist NR oral Drops, Antihistamine/Decongestant, Carbinoxamine Maleate 1 mg, Pseudoephedrine
Hydrochloride, 15 mg, NDC #
60258-435-30, 1 fl. oz
c) Andehist-DM NR Syrup,
Antihistamine/Decongestant/Antitussive, Brompheniramine Maleate 4 mg, Pseudoephedrine Hydrochloride, 45 mg, Dextromethorphan
Hydrobromide, 15
mg, NDC # 60258-444-16, 16 fl. oz,
d) Bromhist-DM
Drops, Brompheniramine Maleate 1 mg, Pseudoephedrine Hydrochloride, 15 mg,
Dextromethorphan
Hydrobromide, 4 mg, NDC # 60258-447-30, 1 fl. oz,
CODE All lots being
recalled.
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Able Laboratories, Inc, Cranbury, NJ,
Manufacturer: Liquisource, Inc, (Able Laboratories), New Brunswick, NJ.
REASON
There is a lack
of assurance that testing for release and stability conformed to standard
operating procedures.
VOLUME OF PRODUCT IN COMMERCE 4
lots
DISTRIBUTION MS
PRODUCT
a)
DYTAN Suspension, Each 4 mL (one teaspoonful) contains: Diphenhydramine
Tannate 25 mg, Rx Only,
NDC 63717-570-99 (Professional sample: Not to besold) and NDC # 63717-570-04, (1/2 fl. oz. and
4 fl. oz.),
b) DYTAN-D, Suspension, Each 5 mL (one teaspoonful) contains:
Diphenhydramine Tannate 25 mg, Phenylephrine
Tannate 7.5 mg, Rx Only, NDC
63717-576-99 (Professional Sample) and NDC # 63717-576-04, (1/2 fl. oz.
and 4 fl. oz.),
CODE All lots being
recalled.
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Able Laboratories, Inc, Cranbury, NJ,
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ..
REASON
There is a lack of
assurance that testing for release and stability conformed to standard operating
procedures.
VOLUME OF PRODUCT IN COMMERCE 2
lots
DISTRIBUTION MS
PRODUCT
Furosemide
Tablets, USP, 20 mg, 1000 count bottles, Rx only, NDC # 0591-3436-10,
CODE
Lot No. T055L04A, Exp
12/06
RECALLING FIRM/MANUFACTURER Vintage
Pharmaceuticals, LLC, Huntsville, AL,
REASON Mold growth on
PRODUCT
VOLUME OF PRODUCT IN COMMERCE 5,064 bottles of
1000
DISTRIBUTION CA
PRODUCT
a)
Hydrocodone Bitartrate & Acetaminophen Tablets, USP, 5 mg/500 mg, NDC #
55154-5549-0, assist bags of 10 tablets,
b) Hydrocodone
Bitartrate & Acetaminophen Tablets, USP, 7.5 mg/500 mg, NDC #
55154-5486-0, assist bags of 10 tablets,
c) Hydrocodone
Bitartrate & Acetaminophen Tablets, USP, 7.5 mg/750 mg, NDC #
55154-5480-0, assist bags of 10 tablets,
CODE
a) Lot number 4C904A, exp. date 9/05;
Lot number 4C904B, exp. date 9/05; Lot number 4D247A, exp. date 12/05;
Lot number 4D247B, exp. date 12/05; Lot number 4D247C, exp. date
12/05; Lot number 4D265A, exp. date 12/05;
Lot number 4F055A, exp. date
10/05; Lot number 4F055B, exp. date 10/05; Lot number 4F055C, exp. date
10/05;
Lot number 4J390A, exp. date 1/06; Lot number 4J390B, exp. date
1/06; Lot number 4M601A, exp. date 3/06;
Lot number 4M601B, exp. date
3/06; Lot number 4M643A, exp. date 3/06; Lot number 4V011A, exp. date
4/06;
Lot number 4V011B, exp. date 4/06; Lot number 4V077A, exp. date
6/06; Lot number 4V077B, exp. date 6/06;
Lot number 4V077C, exp. date
6/06; Lot number 5B231A, exp. date 7/06; Lot number 5B304A, exp. date
8/06;
Lot number 5C449A, exp. date 9/06;
b) Lot number 4H111A, exp. date
11/05; Lot number 4H111B, exp. date 11/05; Lot number 4H111C, exp. date
11/05;
Lot number 4H111D, exp. date 11/05; Lot number 4H111E, exp. date
11/05; Lot number 4H111F, exp. date 11/05;
Lot number 4H111G, exp. date
11/05; Lot number 4H111H, exp. date 11/05; Lot number 4H111J, exp. date
11/05;
Lot number 4D258A, exp. date 12/05; Lot number 4D258B, exp. date
12/05; Lot number 4K516A, exp. date 2/06;
Lot number 4K516B, exp. date
2/06; Lot number 4K516C, exp. date 2/06; Lot number 4K516D, exp. date
2/06;
Lot number 4K516E, exp. date 2/06; Lot number 4K516F, exp. date
2/06; Lot number 4P804A, exp. date 4/06;
Lot number 4P804B, exp. date
4/06; Lot number 4P804C, exp. date 4/06; Lot number 4P804D, exp. date
4/06;
Lot number 4V024A, exp. date 6/06; Lot number 4V024B, exp. date
6/06; Lot number 5C390A, exp. date 9/06;
c) Lot number 4V990A, exp. date
6/06; Lot number 5C474A, exp. date 9/06.
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Cardinal Health, Zanesville, OH,
Manufacturer:
Able Laboratories, Inc, South
Plainfield, NJ.
REASON Recalled at the request of the
manufacturer, because of serious concerns that the products were not produced
according to quality assurance standards.
VOLUME OF PRODUCT IN
COMMERCE 21,400 bags/10 tablet blisters
DISTRIBUTION
OH
PRODUCT
a)
Indomethacin extended release capsules, USP 75 mg, 60 count bottles, NDC #
62584-312-60,
b) Propoxyphene Napsylate and
Acetaminophen tablets, USP 100 mg/650 mg tablets, Packaged in 100 count
box (each box containing 10 blister cards x 10 tablets per card), NDC #
62584-919-01,
c) Propoxyphene Napsylate and
Acetaminophen tablets, USP 100 mg/650 mg tablets, Packaged 450 count
box
(packaged as 15 cards containing 30 tablets per card), NDC # 62584-919-85
d) Lithium Carbonate Capsules, USP, 300 mg, NDC
#68084- 042-01, package in 100 count box (each box containing
10 blister
cards x 10 tablets per card),
CODE All lots are being
recalled.
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Amerisource Health Services, Columbus, OH,
Manufacturer: Able Laboratories, Inc., South Plainfield, NJ.
REASON
Recalled at the
request of the manufacturer, because of serious concerns that the products were
not produced according to quality assurance standards.
VOLUME OF
PRODUCT IN COMMERCE
a) 34,400 bottles
b) 11,656/100 count
cartons
c) All lots
d) 451/100 count boxes
DISTRIBUTION
Nationwide
PRODUCT
a) Perfection
Tablets, All New Dietary Food Supplement with Chromium, (Phenylpropanolamine
HCl), 25mg (appetite
suppressant, time release), 120 count bottles, Formulated by Physicians Research Laboratories,
b)
The Perfect Solution, GARPRIN Tablets, All Natural Dietary Food Supplement,
For The Heart, Pharmaceutical
Grade, 60 count bottles, each tablet contains:
Garlic Odorless 325 mg, White WIllow Extract 100 mg, Asprin 93
mg,
Magnesium Stearate,
CODE All
lots
RECALLING FIRM/MANUFACTURER Physicians Research
Laboratories, Hermitage, TN
REASON
a) Unapproved New
Drug; product contains Phenylpropanolamine;
b) Unapproved New Drug;
product contains Aspirin
VOLUME OF PRODUCT IN COMMERCE
a)
50 bottles;
b) 11 bottles
DISTRIBUTION Nationwide
PRODUCT AZO
Standard Phenazopyridine Hydrochloride 95 mg tablets packaged in cellophane
blister strip packs in cartons of 12’s and 30’s.
CODE
205070 205071 207013 207014 207015 207016
207017 301011 301012 301013 303088 303089 304175 304176 304177 308102 308103
310032 310033 401192 401194 402002 402004 308100 308101 401193, 401193-WI,
402001, 402003, 402003-WI, A301 A402, A405, A408
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Polymedica Pharmaceuticals (USA)
Inc, Woburn, MA
Manufacturer: Able
Laboratories, Inc., South Plainfield, NJ.
REASON Product may not meet quality
standards.
VOLUME OF PRODUCT IN COMMERCE 3 million
units
DISTRIBUTION Nationwide
PRODUCT
a)
Indomethacin Extended Release Capsules, 75 mg.; an Rx oral nonsteroidal
anti-inflammatory; the capsules were
packaged in the following
configurations: Product no. 1518-0: 30 capsules, Product no. 1518-2: 14
capsules,
Product no. 1518-3: 20 capsules; NDC #53265-0269-10,
b) Promethazine HCL Tablets, 25 mg.; an Rx oral
antiemetic/antivertigo agent; the tablets were packaged in the following
configurations: Product no. 1754-0: 12 tablets, Product no. 1754-1: 10
tablets, Product no. 1754-6: 20 tablets, Product no. 1754-8: 2 tablets, Product no. 1754-9: 30 tablets, Product no. 4168-0: 5
tablets; NDC
#53265-0406-10 and 53265-0406-11,
c) Hydrocortisone
Acetate Suppositories, 25 mg.; an Rx rectal anti-inflammatory; the
suppositories were packaged 12 per carton, Product no. 2586-0, NDC
#53265- 761-12,
d) Naproxen Sodium Tablets, 275 mg.; an
Rx oral nonsteroidal anti-inflammatory; the tablets were packaged in the
following configurations: Product no. 3761-0: 20 tablets, Product no. 3761-2:
30 tablets, Product no. 3761-4: 14 tablets; NDC #53265-0363-10,
e) Naproxen Sodium Tablets, 550 mg.; an Rx oral
nonsteroidal
anti-inflammatory; the tablets were packaged in the following
configurations: Product no. 3762-2: 16 tablets, Product no. 3762-3: 20
tablets, Product no. 3762-4: 21 tablets, Product no. 3762-5: 30 tablets,
Product no. 3762-7: 14 tablets; NDC #53265- 0364-10 and 53265-0364-50,
f) Prochlorperazine Suppositories, 25 mg.; an Rx rectal
anti-emetic; the suppositories were packaged 12 per carton, Product no.
4720-0, and 3 per carton, PRODUCT no. 4720-2; NDC #53265-245-12,
g) Clorazepate Dipotassium Tablets, 15 mg.; an Rx oral
Schedule
C-IV narcotic tranquilizer; the capsules were packaged 12 tablets per
bottle, Product no. 4586-1; NDC #53265-0050-10,
h)
Acetaminophen/Hydrocodone Tablets, 325 mg/5 mg.; each tablet contains 325
mg. acetaminophen and 5 mg. hydrocodone bitartrate; an Rx oral Schedule
C-III narcotic analgesic; the tablets were packaged in the following
configurations: Product no. 5523-0: 20 tablets, Product no. 5523-1: 10
tablets; NDC #53265-0345-10 and 53265-0345-50, CODE
a) Lot no’s: 1518-0: 30 capsules, lots
5061164, 5059120, 4352010, 4351012, 4310016, 4286128, 4181219; Lot no’s:
1518-2: 14 capsules, lots 5011138, 4293139, 4287171, 4275220, 4252178,
4239082, 4233071; Lot no’s: 1518-3: 20 capsules, lots 5081122, 5018202, 4296012, 4293215, 4211024, 4184021;
b) Lot no’s: 1754-0: 12 tablets, lots
5081104, 5034132, 4336118; Lot no’s: 1754-1: 10 tablets, lots 5119018,
5059212,
5059170, 5012116, 4282010; Lot no’s: 1754-6: 20 tablets, lots
5075141, 5007010; Lot no’s: 1754-8: 2 tablets, 5011200, 4343148, 4322184; Lot no’s: 5105023, 5052147, 4329031;
Lot no’s: 4168-0: 5
tablets, 5059173, 4317015;
c) Lot no’s: 510982, 5087159, 5041208, 5025192,
4336143, 4324033, 4314175, 4302031, 4271064, 4247046, 4205053, 4189169,
4177050, 4126092, 4110131, 4098145, 4093058, 4065043, 4055252, 4042112, 4037042, 3335171, 3323163, 3275104;
d) Lot no’s: 5028018, 5028019,
5004180, 4302049; Lot no’s: 5124222, 5122215, 4316020; Lot no’s:
5063097, 5039286, 4349219, 4322117;
e) Lot no’s: 5133016, 5062140; Lot
no’s: 5133017, 5075216, 5069164, 4328072; Lot no’s: 5013121, 4363121; Lot no’s: 5105008, 5053197;
Lot no’s: 5067184, 4350160;
f) Lot no's:
5136195, 5111193, 5089185, 5084104, 5046150, 5038196, 5033119, 5025125,
4358077, 4356255, 4337065,
4334241, 4328084, 4323077, 4253038, 4253039,
4229146, 4216160, 4216159, 4208224, 4205088, 4111138, 4111139,
4070159,
4070160, 4055221, 4029064, 4013143; Lot no's: 5138151, 5136196, 5055248,
5026164, 5012156,
4344061, 4322169, 4301166, 4223148, 4223147,
4132175, 4106055, 4091166, 4091165, 4042127;
g) Lot no's: 5104004,
5090012, 5052111, 5011130, 4364154, 4321110, 4132052, 4077066;
h) Lot
no’s: 5066163, 5046118, 5033133, 4253011, 4132127, 4068082, 3345017,
3343008, 3272145; Lot no’s: 5124161, 5066179, 4316024, 4153172, 4089011, 4068131, 4013087, 3360002, 3288116, 3283003, 3272147
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Allscripts LLC, Libertyville, IL,
Manufacturer:
Able Laboratories, South
Plainfield, NJ.
REASON Allscripts repackaged products being
recalled by the manufacturer, Able Laboratories, due to a lack of assurance that
testing conducted for release and stability conformed to standard operating
procedures.
VOLUME OF PRODUCT IN COMMERCE 10,828
capsules, 280,456 tablets, 11,976 suppositories
DISTRIBUTION
Nationwide
PRODUCT
a)
The Master’s Miracle 1st Edition Video,
b) Natural
Solutions for Optimum Health & Wealth (The Master’s Miracle Cassette),
c) The Master’s Miracle 2nd Edition Video,
d) Booklet - Secrets of pH/Dr. Cochran,
e)
Video - Testimonial,
f) Booklet - Master’s Miracle Product
Usage (White Booklet),
g) Booklet - Secrets of pH/Dr.
Cochran,
h) Cassette - pH Miracle/Dr. Cochran,
i) Cassette - Training School 101,
j) DVD -
Making A Difference DVD 2003,
k) Video- The Master’s
Miracle 3rd Edition,
l) Cassette - Product &
Opportunity Testimonials 2004,
m) CD- Product &
Opportunity Testimonials 2004,
CODE
a) Product ID 7703, 7704, 7913, discontinued
date 08/2003;
b) Product ID 7701, 7688, 8975, discontinued date
02/2004;
c) Product ID 7703, 7704, 7913, discontinued date 02/2004;
d)
Product ID 8904, 8905, 8908, discontinued date 03/2004;
e) Product ID 8984,
8985, discontinued date 04/2004;
f) Product ID 7698, discontinued date
04/2004;
g) Product ID 10925, 10936, 10937, discontinued date 11/2004;
h) Product ID 7896, 7904, 7905, discontinued date 11/2004;
i) Product ID
7918, 7923, 8038, discontinued date 11/2004;
j) Product ID 9851, discontinued
date 02/2005;
k) Product ID 7703,7705, 7913, discontinued date 02/2005;
l)
Product ID 11571, 11572, 11573, discontinued date 02/2005;
m) Product ID
11574, 11575, 11576, discontinued date 05/2005
RECALLING
FIRM/MANUFACTURER The Master’s Miracle, Maple Grove, MN
REASON
Misbranded:
promotional material makes unapproved drug claims.
VOLUME OF PRODUCT
IN COMMERCE 329,028 units
DISTRIBUTION Nationwide and
Canada
PRODUCT
a)
ACETAMINOPHEN/CODEINE NO.3 Tablets, (CODEINE PHOSPHPHATE 30 mg (WARNING: MAY
BE HABIT FORMING.) and ACETAMINOPHEN 300 mg), 30 Tablet bottles, NDC
54868-0072-1,
b) PROPOXYPHENE NAPSYLATE/ACETAMINOPHEN
(TABLETS, USP), 100mg/650mg, 15, 20, 30, 40 and 50 Tablet bottles,
NDC
54868-0073-1, 30 tablets; NDC 54868-0073-3, 15 tablets; NDC 54868-0073-4, 20
tablets; NDC 54868-0073-5,
50 tablets; NDC 54868-0073-7, 40 tablets; and NDC
54868-0073-9, Relabel only,
c) HYDROXYZINE HCL,
(HYDROXYZINE HCl Tablets, USP), 25 mg, 10 and 30 Tablet bottles, NDC
54868-0063-3, 30 tablets; and NDC 54868-0063-9, 10 tablets,
d) INDOMETHACIN, (INDOMETHACIN CAPSULES, USP), 25 mg, 30
and 60
Capsule bottles, NDC 54868-0074-3 25 mg 30
capsules; NDC 54868-0074-5 25 mg
60 capsules,
e) PHENAZOPYRIDINE, (PHENAZOPYRIDINE HCL
TABLETS, USP), 100 mg, 10, 20 and 30 Tablet bottles, NDC 54868-0249-0 100 mg, 10 tablets; NDC 54868-0249-2 100 mg, 30 tablets; NDC
54868-0249-3
100 mg, 20 tablets,
f) PROMETHAZINE 12.5 mg Supp, NDC
54868-4794-0, Relabel only,
g) METHYLPHENIDATE
HYDROCHLORIDE, (METHYLPHENIDATE HCL TABLETS, USP), 10 mg, 25 Tablet bottles,
NDC 54868-0733-5 10 mg, 25 tablets,
h) CARISOPRODOL,
(CARISOPRODOL TABLETS, USP), 350 mg, 20, 30, 50, 60 and 90 Tablet bottles,
NDC 54868-0816-2 350 mg, 20 tablets; NDC 54868-0816-3 350 mg, 30 tablets;
NDC 54868-0816-4 350 mg, 60 tablets; NDC 54868-0816-5 350 mg, 50
tablets; NDC 54868-0816-8 350 mg, 90 tablets; and NDC 54868-0816-6 350 mg,
Relabel only,
i)INDOMETHACIN SR, (INDOMETHACIN CAPSULES,
USP), EXTENDED RELEASE CAPSULES, 75 mg, 15 and 30 Capsule bottles, NDC
54868-0922-1 75 mg, 30 capsules; NDC 54868-0922-7 75 mg, 15 capsules; and NDC
54868-0922-2 75 mg, Relabel only,
j) BUTALBITAL
COMPOUND/APAP, (BUTALBITAL, USP 50 mg (WARNING: MAY BE HABIT FORMING.), APAP
(ACETAMINOPHEN) 325 mg, CAFFEINE, USP 40 mg), 30 Tablet bottles, NDC 54868-1036-1 30
tablets
k) LITHIUM CARBONATE EXTENDED
RELEASE TABLETS, USP, 300 mg, 60 tablet bottles, NDC 54868-5239-0 60
tablets,
l) PROMETHAZINE, (PROMETHAZINE HYDROCHLORIDE
TABLETS, USP), 12.5 mg, 10 and 15 Tablet bottles, NDC 54868-5121-0 12.5 mg 15 tablets; NDC 54868-5121-1 12.5 mg 10 tablets,
m) METHAMPHETAMINE HYDROCHLORIDE, (METHAMPHETAMINE HCL
TABLETS,
USP), 5 mg, 60 Tablet bottles, NDC 54868-5136-0 5 mg 60 tablets,
n) HYDROCODONE/ACETAMINOPHEN, (HYDROCODONE BITARTRATE 5 mg
(WARNING: MAY BE HABIT FORMING) ACETAMINOPHEN 325 mg TABLETS, USP), 30
Tablet bottle, NDC 54868-5146-0 5mg/325mg 30 tablets,
o) HYDROCODONE BITART/ACET, HYDROCODONE BITARTRATE 7.5 MG
(WARNING: MAY BE HABIT FORMING) ACETAMINOPHEN 325 MG TABLETS, USP), 30
TABLET BOTTLES, NDC 54868-5167-0 7.5mg/325mg 30 tablets,
p) LITHIUM CARBONATE 300 mg, NDC 54868-1335-2 (Relabel only),
q) INDOMETHACIN, (INDOMETHACIN CAPSULES, USP), 50 mg, 20,
30 and
40 Capsule bottles, NDC 54868-0875-2 50 mg 30 capsules; NDC 54868-0875-4 50
mg 40 capsules; NDC 54868- 0875-6 50 mg 20 capsules
r)
PHENAZOPYRIDINE (PHENAZOPYRIDINE HCL TABLETS, USP), 200 mg, 5, 6, 10, 15, 20
and 30 Tablet bottles, NDC 54868-0250-1 200 mg, 10 tablets; NDC 54868-0250-2
200 mg, 20 tablets; NDC 54868-0250-4 200 mg, 5 tablets; NDC 54868-0250-6
200 mg, 6 tablets; NDC 54868-0250-7 200 mg, 15tablets; and NDC 54868-0250-8
200 mg, 30 tablets,
s) PROMETHAZINE HCL SUPPOSITORIES
USP, 25 mg, 2 and 6 Suppositories, NDC 54868-0601-0 25 mg, 6
suppositories; NDC 54868-0601-1 25 mg, 2 suppositories,
t) PROMETHAZINE, PROMETHAZINE HCL USP SUPPOSITORIES, 50 mg,
4 Suppositories, FOR RECTAL ADMINISTRATION, NDC 54868-1613-1 50 mg, 4
suppositories,
u) PROMETHAZINE (PROMETHAZINE HYDROCHLORIDE
TABLETS, USP), 25 mg, 10, 15, 20, and 30 tablet bottles, NDC 54868-1323-1
25mg 10 tablet; NDC 54868-1323-4 25 mg 15Tablets; NDC 54868-1323-5 25mg 20
tablets; NDC 54868-
1323-6 25mg 30 tablets; NDC 54868-1323-0 (Relabel
only),
CODE All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Physicians
Total Care, Inc, Tulsa, OK,
Manufacturer: Able
Laboratories, Inc, South Plainfield, NJ.
REASON Lack of assurance that testing done for
release and stability conformed to standard operating procedures (by Able
Labs)
VOLUME OF PRODUCT IN
COMMERCE
DISTRIBUTION Nationwide
PRODUCT Vinorelbine
Tartrate Injection, 10mg/mL, 1 and 5 mL vials, For Intravenous Use Only, Rx
only, NDC 10019-970-02 ---- Also under other brand as Vinorelbine Tartrate
Injection, 10mg/mL, ESI Lederle,
CODE 1mL lots: 601248 exp 7/05; 601416 exp 11/05;
A71275 exp 6/06; A93267 exp 8/06. 5mL lots: 601216 exp 7/05; 601217 exp 7/05;
601218 exp 7/05; 601219 exp 7/05; 601412 exp 8/05; A71276 exp 3/06; A71277 exp
3/06; A71278 exp 4/06.
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Anesthesia and
Critical Care, New Providence, NJ,
Manufacturer:
Wyeth Parenterals, Division of Wyeth Holdings Corp, Carolina, PR.
REASON
Exceeds Impurity
Level
VOLUME OF PRODUCT IN COMMERCE 54,505/1 mL vials;
33,055/5 mL vials
DISTRIBUTION Nationwide
PRODUCT
a)
Tebamide Suppositories (Trimethobenzamide HCl Suppositories w/Benzocaine).
Package size: 10s And 50s, Rx product, 200 mg, (Adult), Adult contains
200 mg trimethobenzamide hydrochloride and 2% benzocaine.
b) Tebamide Suppositories (Trimethobenzamide Hci
suppositories
w/Benzocaine). Package size: 10s, Rx product, 100 mg, (Pediatric). Pediatric
contains 100 mg trimethobenzamide hydrochloride and 2% benzocaine,
CODE
a) Lot 010804001 (exp 1/06)
Lot
010804002 (exp 2/06) Lot 010804003 (exp 10/05)
b) Lot 010704001 (exp
9/05)
RECALLING FIRM/MANUFACTURER G & W Labs, Inc.,
South Plainfield, NJ,
REASON Failure to meet assay specs through
expiration date for benzocaine.
VOLUME OF PRODUCT IN
COMMERCE 85,764 boxes
DISTRIBUTION Nationwide
PRODUCT Premarin
(conjugated estrogens) USP, 1.25 mg, 100 count tablet bottles, NDC #
0046-0866-81
CODE Lot 034038B,
expiration date July 31, 2005
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Amerisource Health Services,
Columbus, OH,
Manufacturer: Wyeth
Pharmaceuticals, Rouses Point, NY.
REASON Product does not conform to the current USP
dissolution specifications for Conjugated Estrogens.
VOLUME OF
PRODUCT IN COMMERCE 10,658/100 tablet
bottles
DISTRIBUTION Nationwide
PRODUCT Climara
Pro (Estradiol/Levonorgestrel Transdermal System) 0.045/0.015 mg/day. Rx only,
CODE
Lot 040731, Exp.
10/06
RECALLING FIRM/MANUFACTURER
Recalling Firm: Berlex,
Inc, Wayne, NJ, .
Manufacturer: 3M Pharmaceuticals,
St. Paul, MN.
REASON Mispackaging: Within the batch, pouches
with “Sample-Not For Sale” labeling is intermingled with correct trade foil
pouches.
VOLUME OF PRODUCT IN COMMERCE 40,931
cartons
DISTRIBUTION Nationwide
PRODUCT HYDROCODONE BITARTRATE AND ACETAMINOPHEN CAPSULES, 5 mg/500 mg, 100 capsule bottles, sold under two labels: (1) Mallinckrodt / Tyco Healthcare brand, with NDC #0406-4357-01, UPC 3 0406 4357 019.
(2) UAD brand under the product name: LORCET
-HD, with NDC #0785-1120-01, UPC 3 07851 12001 8,
CODE
1) Lot #s 4357D06966, 4357D06967,
4357D11149, 4357D11150, 4357E06904, 4357E13927, 4357E15890, 4357H00966,
4357H00665, 4357H07025, 4357H10604, 4357H11513;
2) Lot
#UL0301A
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Mallinckrodt, Inc, Berkeley, MO,
Manufacturer: Mallinckrodt, Inc, Hobart, NY.
REASON
Failure to comply with good
manufacturing practices resulting in inadequate blend
validation.
VOLUME OF PRODUCT IN COMMERCE 109,256
bottles
DISTRIBUTION Nationwide
WEEK ENDING JULY 30
PRODUCT Betac®, Ascorbic Acid
Injection, USP, 500mg/mL, 50mL vial Rx Only, Sterile injection solution, for
prescription use, NDC 62086-139-50
CODE 040816,
040718, 040615, 040520, 040517, 040402, 040216, 040120, 031219, 031006, 030926,
030717
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bioniche
Animal Health, Athens, GA,
Manufacturer: Bioniche Pharma, Casla, Ireland.
REASON
Particulate Matter (calcium
oxalate)
VOLUME OF PRODUCT IN COMMERCE 118,370
units
DISTRIBUTION Nationwide
PRODUCT
(1) Nicotine Polacrilex Gum,
USP, 2mg (nicotine), blister cards of 110 chewing pieces (Starter Kits) and 220
chewing pieces (Refills), over the counter, Rx Only. The product was sold under
the following private labels labeled in part: (1) CVS® Pharmacy NICOTINE
POLACRILEX GUM, USP, 2 mg (nicotine), ORIGINAL, STARTER KIT, NDC
59779-600-62;
(2) Nicotine Polacrilex Gum, USP, STOP SMOKING AID,
2mg(nicotine), STARTER KIT, [Note: this was manufactured for Novartis which is
not mentioned in the product labeling] *** NDC 61955-600-62 --- (3) Rugby®,
Nicotine Polacrilex Gum USP, 2mg (nicotine), STOP SMOKING AID, STARTER KIT, NDC
0536-3106-23 --- (4) BERKLEY & JENSENô Nicotine Polacrilex Gum, USP, STOP
SMOKING AID, 2mg (nicotine), REFILL, NDC 71114-4210-3.
CODE
Lot 2NB04043 (exp. Date February 2006),
Lot
2NB04048 (exp. Date February 2006)
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Watson Pharmaceuticals, Inc.,
Corona, CA,
Manufacturer: Watson
Laboratories, Inc., Copiague, NY.
REASON Degradation Failure.
VOLUME OF PRODUCT IN
COMMERCE 26,160 cartons of 110 chewing pieces and 5,704 cartons of 220
chewing pieces
DISTRIBUTION Nationwide
PRODUCT Glucotrol XL (Glipizide)
Extended Release Tablets, 10mg, 100 count bottles, Rx only, NDC 0049-1560-66,
CODE
4XP036A
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Pfizer, Inc., Cruze Davila, NY
Manufacturer: Pfizer Pharmaceuticals,
LLC, Barceloneta, PR.
REASON Incorrect
Tablet Imprint; tablet incorrectly imprinted as Glipizide XL (the generic name)
instead of Glucotrol XL (the brand name).
VOLUME OF PRODUCT IN
COMMERCE 1,920 units
DISTRIBUTION Nationwide
PRODUCT Premarin 0.3 mg
(Conjugated Estrogens Tablets, USP), 100 tablet bottles, Rx only, NDC
0046-0868-81.
CODE Lot 07632 esp.
07/05
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rx PAK,
Memphis, TN
Manufacturer: Wyeth
Pharmaceuticals, Rouses Point, NY.
REASON Dissolution Failure (by manufacturer)
VOLUME OF
PRODUCT IN COMMERCE 29,898 units
DISTRIBUTION Nationwide
PRODUCT Premarin 1.25 mg
(Conjugated Estrogens Tablets, USP), 100 count bottles, Rx only, NDC
0046-0866-81.
CODE
Lot 08182 Exp 07/05, Lot 11048
Exp 07/05,
Lot 13724 Exp 07/05, Lot 14346 Exp 07/05
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Rx PAK, Memphis, TN
Manufacturer: Wyeth Pharmaceuticals, Rouses
Point, NY.
REASON Dissolution
Failure (by manufacturer)
VOLUME OF PRODUCT IN COMMERCE 41,161
units
DISTRIBUTION Nationwide
Perrigo Company Announces Nationwide Recall of Infants’ Oral Drops Containing Enclosed Syringe
The Perrigo Company (Nasdaq: PRGO; TASE) is voluntarily recalling all lots of concentrated infants’ drops that are packaged with a dosing syringe bearing only a “1.6 mL” mark containing:
The dosing syringe may be confusing in determining the proper dose for infants under 2 years of age as directed by a doctor and could lead to improper dosing, including overdosing. The following products are being recalled to the retail level:
The directions on the bottle and carton labeling for infants ages 2-3 years and weighing 24-35 pounds allow safe and effective dosing for this age and weight group. However, these products are also intended for use by infants younger than 2 years and weighing less than 24 pounds. The labeling directs consumers to ask a doctor for dosing directions for this age and weight group.
The products are being recalled because the oral dosing syringe enclosed with these products is not marked so as to accurately measure doses less than 1.6 mL when prescribed by physicians for infants younger than 2 years and weighing less than 24 pounds. Until recently these products were provided with a dropper, not the oral dosing syringe, and the dropper had two markings on it (“0.4 mL” and “0.8 mL”). The single mark on the current syringe along with the changeover from the dropper to this syringe has caused some confusion among consumers and health-care professionals and may lead to improper dosing. Taking more than the recommended dose (overdose) of acetaminophen may cause liver damage. The products, however, are safe and effective when accurately dosed. Parents or caregivers who have questions should discuss with their doctor how to accurately determine the proper dose.
The recalled products were sold nationally at retail chains under the following store-brand labels: American Fare, Best Choice, Brooks, Berkley & Jensen, CVS, Dollar General, Eckerd, Equaline, Equate, Family Dollar, Food Lion, Good Neighbor, GoodSense, Healthy Generations, Health Pride, Hy-Vee, Kroger, Leader, Longs, Major, Medicine Shoppe, Meijer, Parklane, Publix, Rite Aid, Safeway, Shop Rite, Sunmark, Target, Today’s Health, Top Care, Walgreen, Western Family, and Winn Dixie.
Questions or concerns about a product described in this recall should be directed to Perrigo’s Consumer Affairs Department, toll free, at 800-321-0105.