WEEK ENDING MAY 19
PRODUCT Various sterile skin preparations:
a) Clinipad Alcohol Prep, Antiseptic. NDC #19154-1245-3.
b) Clinipad Alcohol Prep. NDC #19154-1245-8
c) Cliniswab Iodophar PVP Povidone Iodine USP, Antiseptic,
1 Saturated Swabstick. NDC #19154-1241-2
d) Cliniswab Iodophar PVP Scrub Povidone Iodine USP 3
Saturated Swabsticks. NDC #19154-1242-7
e) Cliniswab Isoprophyl Alcohol Antiseptic, 1 Saturated
Swabstick. NDC #19154-1245-9
f) Cliniswab Iodophar PVP Scrub, Povidone Iodine USP,
Antiseptic, 1 Saturated Swabstick. NDC #19154-1242-9
g) Cliniswab Iodophar PVP Povidone Iodine USP, Antiseptic,
3 Saturated Swabsticks. NDC #19154-1241-3
h) Cliniswab Iodophor PVP Antiseptic Cleanser, Povidone
10% USP, 3 Saturated Swabsticks. NDC #19154-1241-0
i) Clinipad Iodophor-PVP, Povidone-Iodine USP, Titratable
Iodine 1% Solution, Antispetic 1 fluid ounce (30 ml). NDC #19154-1241-4
j) Clinidine Povidone Iodine 1% USP Solution Topical
Anti-Infective, 1 fluid ounce (30ml). NDC #19154-1241-5
k) Clinidine Povidone Iodine 10% USP Solution Antiseptic
Cleanser, 3/4 fluid ounce (30ml). NDC #19154-1241-7.
l) Clinidine Ointment Povidone USP Titratable Iodine
1% Antiseptic Germicide net weight .033 ounce (1.0g). NDC #19154-4341-4
m) Clinipad Iodophor PVP Povidone Iodine USP 1 Prep Pad.
NDC #19154-1241-1.
CODE
Clinipad Reorder Code
Lot No.
Product Code
a) 0110
806610
0110
0110BS
802270
0110BS
b) 0250R
716313
0250R
c) 1241S-B
812304, 811612
1261S
1261S
812467
HK1241S
HK1241S
919882
1241S-B
d) HK1244S
919862
HK1244S
e) 1251S-B
805817
1251S-B
f) 1262S
920324, 918333
810014, 812302
1262S
g) 1291S-B
715786, 812873
129S-B
HK1291S
911485, 919827
HK1291S
h) 1291SK
919249
1291SK
i) 3941S-BC
812422
3941S-BC
HK3941S
812891, 911939
HK3941S
j) 3943S-B
917141
3943S-B
k) 3944S-B
919888
3944S-B
l) 4339SC
811937, 920315
4339SC
HK4339S
919864, 812893
HK4339S
m) 9153SBD
812556, 919526
HK9153S
HK9153S
919915
9153SBD.
MANUFACTURER Clinipad Corporation, Charlotte, North Carolina.
RECALLED BY The Clinipad Corporation, Rocky Hill, Connecticut
DISTRIBUTION Nationwide and international.
QUANTITY Undetermined.
REASON Microbial contamination.
PRODUCT Herbal dietary supplements in oral dose
capsules: a) Diabetes Hypoglucose Capsules,OTC, 70 capsules per bottle;
b) Pearl Hypoglycemic Capsules, 60 capsules per bottle.
CODE All lot codes.
MANUFACTURER a) Pingchuan Group*Pingchuan International
Economic Trade Harbin, China; b) Tongyi Tang Pharmaceutical, Harbin, China.
RECALLED BY Chinese Angel Health Products, Inc., Blaine,
Washington (responsible firm)
DISTRIBUTION Nationwide and international.
QUANTITY a) Approximately 2,139 bottles; b) Approximately
535 bottles were distributed.
REASON Misbranding - Product contains the undeclared
antidiabetic prescription drug glyburide.
PRODUCT Various Nonsterile Skin Preparations:
1) CLINIPAD Acetone Alcohol Prep, 1 Prep Pad, 100 units/folding
box, 10 boxes/case and 8,000/case. NDC #NDC 19154-1247-2
2) CLINISWAB Iodophor-PVP Scrub, Povidone-Iodine USP,
3 Saturated Swabsticks/unit, 25 units/folding box; 10 boxes/case 2490SW.
NDC 19154-1242-2
3) CLINIPAD Iodophor, Poloxamer-Iodine Complex, 3 Towelettes,
Antiseptic, 1000/case. NDC 19154-9152-6
4) CLINIPAD Isopropyl Alcohol 70%, 1 fl. oz. (30 ml),
50 units/folding box; 4 boxes/case and 200 units/case. NDC 19154-1245-5
5) Clinipad Alcohol Prep, 200 units/folding box, 10 boxes/case.
NDC #19154-0110-2
6) Clinipad Alcohol Swab, 200 units/folding box, 10 boxes/case.
NDC #19154-0110-2
7) Cliniswab Lemon Glycerin, 3 Saturated Swabsticks/unit,
25 units/folding box, 10 boxes/case/.
8) Cliniswab Benzalkonium Chloride, 3 Saturated Swabsticks/unit,
25 units/folding box, 10 boxes/case. NDC #19154-3912-2
9) Cliniswab Benzalkonium Chloride, 3 Saturated swabsticks/unit,
500 units/case. NDC #19154-3911-1
10) Cliniswab Tincture of Green Soap, 1 Saturated Swabstick,
50 units/folding box, 10 boxes/case. NDC #19154-1235-1
11) Cliniswab Isopropyl Alcohol, 1 and 3 Saturated Swabsticks/unit,
25 units/folding box, 10 boxes/case and 50 units/folding box, 10 boxes/case.
NDC #19154-1245-1 and 19154-1245-6.
12) Cliniswab Povidone-Iodine USP, 1 Saturated Swabstick/unit,
50 units/folding box, 10 boxes/case. NDC #19154-9153-2
13) Cliniswab Iodophor-PVP Scrub, Povidone-Iodine USP,
1 Saturated Swabstick/unit, 50 units/folding box, 10 boxes/case. NDC #19154-1242-1
14) Cliniswab Iodophor, Poloxamer-Iodine Complex, 3 Saturated
Swabsticks/unit, 25 units/folding box, 10 boxes/case. NDC #19154-9152-3
15) Cliniswab Iodophor-PVP Povidoone-Iodine, 3 Saturated
Swabsticks/ unit, 25 units/folding box, 10 boxes/case. NDC #19154-9153-3.
16) Clinipad Antiseptic, 1 Towelette, 100 units/folding
box, 10 boxes/case and 2,500 units/case. NDC #19154-3912-3
17) Clinipad Iodophor, Poloxamer-Iodine Complex, 3 Towelettes,
Antiseptic, 100/case. NDC #19154-9152-6
18) Clinidine Povidone Iodine USP Solution, 1 fluid ounce
(30ml), 50 units/folding box, 4 boxes/case. NDC #19154-9153-4
19) Clinidine Ointment, 0.33 ounce (1.0g), 250 units/folding
box, 4 boxes/case. NDC #19154-4341-2
20) Clinidine Solution, Povidone Iodine, 1 Gal. (3.78L),
16 fl. oz. (473 ml), 8 fl. oz. (237 ml), 4 fl. oz. (118 ml), 2 fl. oz.
(59 ml), 1 fl. oz. (30 ml). NDC 19154-9153-6, NDC 19154-9153-7, NDC 19154-9153-5,
NDC 19154-4444-0, NDC 19154-4444-1, NDC 19154-4444-9, NDC 19154-4445-1
21) Cliniscrub Surgical Scrub, Povidone Iodine, 1 gallon
(3.78L), 4 fluid ounces (118ml), 2 fluid ounces (50ml), 50 units/case.
NDC #19154-4471-4, NDC #19154-4471-6, NDC #19154-4474-1
22) Clinipad Iodophor PVD, Povidone Iodine USP, 1 Prep
Pad, 200 units/folding box, 10 boxes/case. NDC #19154-9153-1
23) Moore Medical, Povidone Iodine USP Antiseptic Swabstick,
Reorder #08485, 50 units/folding box, 10 boxes/case. NDC #00839-8074-04
24) Randex Hemmorrhoidal Wipes, 900 units/case and 100
units/case folding box, 10 boxes/case. NDC #19154-3912-9
25) Bidette Cloth Towelettes, 100 units/folding box,
10 boxes/case. NDC (n/a)
26) Vionex Antimicrobial Skin Wipe Towelette (Metrex
MX-1510), 50 units/folding box, 10 boxes case. NDC #55443-0102-1
27) E-Z-Prep, 1 Winged Sponge, Iodophor Scrub Solution,
50 units/case. NDC #19154-0310-1
28) E-Z Prep, 2.8" Sponge Sticks Povidone-Iodine Topical
Solution, 70 units/case. NDC #19154-1480-1
29) E-Z-Prep, 4 Winged Sponges, Iodophor Scrub Solution,
50 units/case. NDC #19154-0311-5
30) E-Z Prep Solo-Prep Topical Gel, 115 units/case. NDC
#19154-1459-1
31) Clinidine Solution, Povidone Iodine, 4-fluid ounces
(118ml), and 2-fluid ounces (59ml), 50 units/case. NDC #19154-4444-1 and
NDC #19154-4444-9
32) E-Z-Prep Scrub Solution, 4-fluid ounces (118ml),
115 units/case. NDC #19154-0311-4.
33) E-Z-Prep Paint Solution, 2.7-fluid ounces (80ml),
115 units/case. NDC #19154-1460-2.
CODE
Clinipad Reorder Cod
Lot No.
1) 0310, 0310SB
All lots
2) 1244
All lots
3) 2490SW
All lots
4) 3925, 3925D, 3925B
All lots
5) 0610
920842
6) 0610E
913380
7) 1225
905197, 917536, 913121, 914355
8) 1230, 1230CRB
806552, 813702, 814648
9) 1230BK
807004, 810660, 904181
10) 1235
914805
11) 1245, 1251
715480, 912553, 913661, 914449
12) 1261
913244, 914953, 921951
13) 1262
806550, 913512
14) 1290
914080
15) 1291
912164, 914485, 914962, 921451, 921714
16) 2395, 2395B3
811478, 910288, 911943, 911955, 913496, 921469, 911206
17) 2490SW
All lots
18) 3941
912129, 912448, 914594
19) 4339
916825
20) 4441, 4442, 4443
813184, 913558, 914231, 915916,
4448, 4444, 4444-D
914730, 914478, 807340, 809320,
4446, 4447
913256, 914477, 904783, 808772
21) 4474, 4474-SC
915508, 810288, 916829, 913556
4476, 4471
915421, 915940, 912322, 809454
HK4474
914965
22) 9153
903940, 911636, 911803, 911804,
914127, 920843, 921206, 921456, 913648
23) 93469
913663, 914568
24) 94526, 99619
911275, 911631, 901844, 911272,
912201, 912441, 912985, 913688
25) 99270
913597
26) 99528, 99533
911283, 912850, 913598, 903193
27) 372211
913565
28) HK0593
911734
29) HK0595
919941
30) HK1570
913554
31) HK4444, HK4446
813557, 809427, 807342
32) HK1629
914451
33) HK1630
912323.
MANUFACTURER Clinipad Corporation, Charlotte, North Carolina.
RECALLED BY The Clinipad Corporation, Rocky Hill, Connecticut
DISTRIBUTION Nationwide and international.
QUANTITY Undetermined.
REASON Lack of assurance product meets microbial release
specifications.
PRODUCT 1) CLINIPAD Alcohol Prep, Antiseptic. NDC
#19154-1245-3. Except lot #806610-Product code 0110 tc "Except lot #806610-Product
code 0110 " \l 2 #802270 0110BS tc " #802270 0110BS " \l 2
2) CLINIPAD Alcohol Prep, Antiseptic. NDC #19154-1245-8
Except Lot # 716313-Product code 0250R tc "Except Lot # 716313-Product
code 0250R " \l 2
3) Moore Medical Corp. Alcohol Prep Pad 70% Isopropyl
Alcohol Medium 2 Ply. NDC #00839-8072-06, Reoroder No. 30839 Box/200 Reorder
No. 08481 Box/100
4) CLINIPAD Acetone Alcohol Prep, 1 Prep Pad. NDC #19154-1245-7
5) Steri Wipe 1 Alcohol Swab. NDC #19154-1245-7
6) Rauscher Alcotupf Alkoholtupfer Tampons alcoolises
Alcohol wabs REF ALKT. NDC (n/a)
7) CLINISWAB Compound Benzoin Tincture Topical Protectant,
1 Saturated Swabstick. NDC #19154-1231-2
8) CLINIGUARD Protective Dressing, 1 Saturated Swabstick.
NDC (n/a)
9) CLINISWAB Iodophor PVP Povidone Iodine USP, Antiseptic,
1 Saturated Swabstick. NDC #19154-1241-2 Except Lot # 812304, 811612-Product
code 1261S tc "Except Lot # 812304, 811612-Product code 1261S " \l 2 #
812467 HK1241S # 919882 1241S-B
10) CLINISWAB Iodine Tincture, 2% U.S.P. Topical Anti-Infective,
1 Saturated Swabstick. NDC #19154-1243-3
11) CLINISWAB Iodophor PVP Scrub Povidone Iodine USP
3 Saturated Swabsticks. NDC #19154-1242-7 Except Lot # 919862-Product code
HK1244S tc "Except Lot # 919862-Product code HK1244S D-307-0 " \l 2
12) CLINISWAB Isopropyl Alcohol Antiseptic, 3 Saturated
Swabsticks. NDC #19154-1245-0
13) CLINISWAB Acetone Alcohol Topical Anti-Infective,
1 Saturated Swabstick. NDC #19154-1247-3
14) CLINISWAB Acetone Alcohol Topical Anti-Infective,
3 Saturated Swabsticks. NDC #19154-1247-5
15) CLINISWAB Isopropyl Alcohol Antiseptic, 1 Saturated
Swabstick. NDC #19154-1245-9 Except Lot # 805817-Product code 1251S-B tc
"Except Lot # 805817-Product code 1251S-B " \l 2
16) CLINISWAB Iodophor PVP Scrub, Povidone Iodine USP,
Antiseptic, 1 Saturated Swabstick. NDC #19154-1242-9 Except Lot # 920324,
918333, 810014, 812302-Product code 1262S tc "Except Lot # 920324, 918333,
810014, 812302-Product code 1262S " \l 2
17) CLINISWAB Iodophor PVP Povidone Iodine USP, Antiseptic,
3 Saturated Swabsticks. NDC #19154-1241-3 Except Lot # 715786, 812873-Product
code 1291S-B tc "Except Lot # 715786, 812873-Product code 1291S-B " \l
2 # 911485, 919827-Product code HK1291S tc " # 911485, 919827-Product code
HK1291S " \l 2
18) CLINISWAB Iodophor PVP Antiseptic Cleanser, Povidone
Iodine 10% USP, 3 Saturated Swabsticks. NDC #19154-1241-0 Except Lot #
919249-Product code 1291SK tc "Except Lot # 919249-Product code 1291SK
" \l 2
19) EZ PREP 220 Povidone Iodine (Minimum Available Iodine
0.5%) 2-8" SpongeSticks. NDC #19154-1462-1
20) CLINIPAD IODOPHOR-PVP, Povidone-Iodine USP,Titratable
Iodine 1%, Solution, Antiseptic 1 fl.oz (30ml.). NDC #19154-1241-4
Except Lot # 812422 Product code 3941S-BC # 812891, 911939,
Product code HK3941S tc " # 812891,911939, -------Product code HK3941S
" \l 2
21) CLINIDINE Povidone Iodine 1% USP Solution Topical
Anti-Infective, 1 fl. oz (30 ml). NDC #19154-1241-5 except Lot # 917141-Product
code 3943S-B.
22) CLINIDINE Povidone Iodine 10% USP Solution Antiseptic
Cleanser, 3/4 fl. oz (21ml). NDC #19154-1241-7. Except Lot # 919888-Product
code 3944S-B
23) CLINIDINE OINTMENT Povidone Iodine USP Titratable
Iodine 1% Antiseptic Germicide Net WT.033 oz. (1.0g). NDC #19154-4341-4
Except Lot # 811937, 920315-Product code 4339SC. 919864,
812893-Product code HK4339S tc " 919864, 812893-Product code HK4339S "
\l 2
24) CLINIGUARD Protective Dressing Prep, 1 Prep Pad.
NDC # (n/a)
25) CLINIPAD Iodophor PVP Povidone Iodine USP 1 Prep
Pad. NDC #19154-1241-1Except Lot tc "Except Lot " \l 2 # 812556, 919526
Product code HK9153S # 919915 Product code 9153SBD tc " # 919915 ------Product
code 9153SBD " \l 2
26) CLINIPAD Iodophor, Poloxamer-Iodine Complex, 3 Towelettes,
Antiseptic. NDC #19154-9152-9
27) CLINIPAD Snapsule PVP Iodine Solution 10% USP Swab
Applicator Net 0.67 ml Product No.9151S. NDC #19154-1241-9
28) Cooper Instrument Corporation Antibacterial Probe
Wipes Single Use Packet. NDC (n/a)
CODE All codes except where noted above.
Clinipad Reorder Numbers:
1) 0110, 0110B3, 0110BS, 0110CRB, 0110M, 0110R, 0110T,
0110TA, 99510, 99512, HK0110, 90110
2) 0250B, 0250R
3) 0110H, HK0110H
4) 0310S-B, HK0310S
5) 0510, 0510B, 0510-BT, 93461
6) 0610ER-RAU
7) 1231S-B, HK1231S
8) 1233S-B, HK1233S
9) 1241S-B, 1261S HK1241S
10) 1243S-B, HK1243S
11) 1244S-B, HK1244S
12) 1245S-B, HK1245S
13) 1247S-B, HK1247S
14) 1248S-B, HK1248S
15) 1251S-B, HK1251S
16) 1262S
17) 1291S-B, HK1291S
18) 1291SK, 1291SKB
19) 372201, 3941S-B
20) 3941S-BC, HK3941S
21) 3943S-B
22) 3944S-B
23) 4339S-B, 4339SC HK4339S
24) 8133S-B, HK8133S
25) 9153S-B, 9153-SBD HK9153S
26) HK2490S
27) HK9151S
28) 99529.
MANUFACTURER Clinipad Corporation, Charlotte, North Carolina.
RECALLED BY Clinipad Corporation, Rocky Hill, Connecticut
DISTRIBUTION Nationwide and international.
QUANTITY Undetermined.
REASON Lack of assurance for sterility.
WEEK ENDING MAY 26
PRODUCT Feosol(r) Elixir Iron Supplement Therapy
44mg, in 16-ounce (473ml) bottles.
CODE Lot Numbers: 9H23A and 9J11A.
MANUFACTURER SmithKline Beecham Consumer Healthcare,
Aiken, South Carolina.
RECALLED BY SmithKline Beecham Consumer Healthcare, Parsippany,
New York
DISTRIBUTION Nationwide.
QUANTITY 884 cases (12 bottles per case) were distributed.
REASON Subpotent iron content (stability testing) and
crystalline precipitate.
PRODUCT Albuterol Sulfate Inhalation Solution,
0.083%, in 3 ml unit dose vials, Rx used for the prevention and relief
of bronchospasm.
CODE Lot #A9H045 EXP 8/01.
MANUFACTURER Automatic Liquid Packaging, Woodstock, Illinois.
RECALLED BY Alpharma USPD Inc., Baltimore, Maryland
DISTRIBUTION New York and Missouri.
QUANTITY 2,340 vials were distributed; firm estimates
none remains on the market.
REASON Mislabeling - Exterior holding carton incorrectly
labeled as Ipratropium (vials inside correctly labeled).
PRODUCT Jordan Epinephrine Injection, USP, 1:1000,
1 mg/mL, 1mL ampuls, Rx sterile solution intended for subcutaneous or intramuscular
administration for the treatment of respiratory distress in bronchial asthma
or during severe, acute asthma attacks, severe anaphylactic reactions and
shock, and cardiac arrest to restore cardiac rhythm. NDC #58196-065-31.
CODE Lot Numbers: 980308, 980401, 980402, 980501, 980601,
990205, 990307, 990308.
MANUFACTURER Bioniche Teo, Republic of Ireland.
RECALLED BY Jordan Pharmaceuticals Inc., Elk Grove Village,
Illinois
DISTRIBUTION Pennsylvania, Mississippi, California.
QUANTITY 2,167 100-ampule boxes were distributed.
REASON Subpotency - During stability testing.
PRODUCT Mintezol(r) Chewable (Thiabendazole) Tablets,
USP, 500 mg, in unit dose packages of 36 tablets, Rx for the treatment
of parasitic infections.
CODE Lot Numbers and EXP Dates:
J800 EXP Jan 04, J8001 EXP Jan 04, J8002 EXP Jan 04,
J8003 EXP Jan 04, J8004 EXP Jan 04, J8005 EXP Jan 04, J8011 EXP Feb 04,
J8012 EXP Feb 04, J8013 EXP Mar 04, J8014 EXP Feb 04, J8016 EXP Feb 04,
J8017 EXP Feb 04.
MANUFACTURER Merck and Company, West Point, Pennsylvania.
DISTRIBUTION Nationwide and international.
QUANTITY 24,163 units were distributed.
REASON Use of an unapproved binding agent was used in
formulation.
PRODUCT True Care(tm) Stool Softener with Laxative
Softgels, (Docusate Sodium 100 mg/Casanthranol 30 mg), OTC in bottles of
100.
CODE Lot numbers: 5674A, 5765B, and 5834A.
MANUFACTURER Banner Pharmacaps, High Point, North Carolina.
RECALLED BY Apothecary Products, Inc., Burnsville, Minnesota
DISTRIBUTION Nationwide.
QUANTITY 1,584 bottles were distributed.
REASON Misbranded - Labeling fails to declare dosage
instructions.
PRODUCT Saline Nasal Spray, OTC, in 1.5-ounce white
bottles, under the following labels: Albertson’s, Bi-Mart and Health Pride.
CODE Lot number: 9M97007.
MANUFACTURER Accupac, Inc., Mainland, Pennsylvania.
RECALLED BY Leiner Health Products Inc., Carson, California
DISTRIBUTION Indiana, Oklahoma, Oregon, Pennsylvania.
QUANTITY 30,732 units were distributed.
REASON Products had discoloration and iron contamination.
PRODUCT Meperidine HCL Injection, USP, Rx for relief
of moderate to severe pain, for pre-operative medication, for support on
anesthesia, and for obstetrical analgesia: a) 50 mg/mL in 30mL vial, NDC
#0008-0258-01; b) 100 mg/mL in 20 mL vial, NDC #0008-0259-01
CODE Lot numbers: a) 4970174 EXP 11/00, 4980176 EXP 6/01,
4980216 EXP 7/01, 4990104 EXP 2/02; b) 4970175 EXP 11/00, 4980213 EXP 6/01,
4980214 EXP 9/01, 4990084 EXP 3/02.
MANUFACTURER Wyeth Laboratories, Marietta, Pennsylvania.
RECALLED BY Wyeth Ayerst Laboratories, St. Davids, Pennsylvania
DISTRIBUTION Nationwide.
QUANTITY 95,786 vials were distributed.
REASON Lack of assurance of sterility.
PRODUCT Spartan(r) Antiseptic Hand Cleaner, Hair
& Shampoo, OTC, in 800 mL bags, 1 and 5-gallon pails, and 15, 30 and
55-gallon drums.
CODE Lot Numbers: 0987 through 0993, and all codes prior
to "04/03/00" expiration date.
MANUFACTURER Steiner Company, Inc., Holland, Ohio (packager).
RECALLED BY Spartan Chemical Company, Maumee, Ohio (responsible
firm)
DISTRIBUTION Nationwide.
QUANTITY 100,800 gallons were distributed.
REASON Product contains unapproved dyes.
PRODUCT Americair brand Oxygen Compressed, USP
medical gas in high-pressure cylinders sizes E, D, C and B, Rx for pulmonary
use as directed by a physician for Oxygen deficiency or emergency resuscitation.
CODE All lot numbers including all tanks received by
customers between 4/97 through 4/7/00.
MANUFACTURER Americair of the East Bay, Vacaville, California.
DISTRIBUTION California.
QUANTITY Approximately 2,500 cylinders were distributed.
REASON Current good manufacturing deviations including
but not limited to lack of odor testing prior to distribution.
PRODUCT Copaxone(r) (glatiramer acetate for injection,
formerly known as Copolymer-1) Self Injection Administration package containing
100 units of Alcohol Prep (Swab) recalled by Clinipad Corporation.
CODE The Clinipad lot numbers that had been packaged
into the kits were:
803902, 812094, 812879, 814063, 910806, 814314, 915860,
805963, 812158, 813314, 814747, 910089, 915435, 916061, 805829, 811229,
813550, 815368, 910599, 915110, 916415, 805206, 812091, 813313, 815970,
910594, 915461, 915937, 809016, 811658, 803206, 910559, 910093, 915860,
915504, 809018, 812878, 800521, 910089, 911739, 915728, 917479, 809019,
814065, 910092, 911313, 917040.
COMPONENT MANUFACTURER The Clinipad Corporation, Charlotte,
North Carolina (responsible firm).
RECALLED BY Aventis Pharmaceuticals, Inc., Kansas City,
(distributor)
DISTRIBUTION Nationwide.
QUANTITY 376,689 administration kits were distributed
between 3/19/97 through 3/13/2000.
REASON Administration kits contain alcohol preps for
which Clinipad Company is unable to assure the sterility.
PRODUCT Goldline Brand: a) Doxycycline Hyclate
Capsules, 100 mg, in blister packs in boxes of 100;
b) Indomethacin Capsules, 50 mg, in blister packs in
boxes of 100.
CODE Lot Numbers: a) T-1474 EXP 10/01; b) T-1475 EXP
10/01.
MANUFACTURER Zenith Goldline Pharmaceuticals, Northvale,
New Jersey. International Labs, St. Petersburg, Florida (responsible repacker/packager
(contract).
RECALLED BY Zenith Goldline Pharmaceuticals, Miami, Florida
DISTRIBUTION Nationwide.
QUANTITY a) 604 boxes; b) 366 boxes were distributed;
firm estimated that 50 percent of the product remained on market at time
of recall initiation.
REASON Mislabeling - Indomethacin Capsules were incorrectly
labeled as Doxycycline Hyclate Capsules.
PRODUCT Promethazine with Codeine Cough Syrup (6.25
mg/5 mL and 10 mg/5 mL), in 4 and 16-fluid ounce (pint) bottles, Rx schedule
V narcotic oral liquid for the temporary relief of coughs and upper respiratory
symptoms associated with allergy or the common cold, under the following
labels:
a) MGP, 4-ounce - NDC #60432-606-04 and 16-ounce - NDC
#60432-606-16
b) Zenith Goldline, 16-ounce - NDC #0182-1712-40
c) Major Pharmaceuticals, 4-ounce - NDC #0904-1510-00
and 16-ounce - NDC #0904-1510-16
d) Qualitest, 4-ounce - NDC #0603-1578-54 and 16-ounce
- NDC #0603-1578-58
e) URL, 16-ounce - NDC #0677-0963-33.
CODE Lot Numbers: 22128, 22161, 22238, 22295, 22369,
22500, 22555.
MANUFACTURER Morton Grove Pharmaceuticals, Inc., Morton
Grove, Illinois.
DISTRIBUTION Nationwide.
QUANTITY 54,587 4-ounce bottles and 172,512 16-ounce
bottles were distributed; firm estimated that less than 20% of the product
remained on market at time of recall initiation.
REASON Subpotency of the Promethazine Hydrochloride ingredient.
PRODUCT Clindamycin Phosphate Topical Solution
USP, 1%, Rx, packaged in 1-fluid ounce bottles - NDC #60432-693-30 and
2-fluid ounce bottles - NDC #60432-693-60.
CODE Lot Numbers: 21796 and 22334.
MANUFACTURER Morton Grove Pharmaceuticals, Inc., Morton
Grove, Illinois.
DISTRIBUTION Nationwide.
QUANTITY 5,273 1-ounce bottles and 2,966 2-ounce bottles
were distributed; firm estimated that less than 20 percent of the product
remained on market at time of recall initiation.
REASON One degradant exceeded specification during stability
testing.
PRODUCT Promethazine VC Plain Syrup, (6.25mg/5mL
and 5 mg/5mL), in 4-ounce and 16-ounce (pint) bottles, an Rx oral liquid
intended for the temporary relief of upper respiratory symptoms, including
nasal congestion, associated with allergy or the common cold,distributed
under the following labels:
a) MGP, 4-ounce - NDC #60432-605-04, 16-ounce - NDC #60432-605-16
b) Major Pharmaceuticals, 16-ounce - NDC #0904-1512-16
c) Qualitest, 4-ounce - NDC #0603-1582-54, 16-unce -
NDC #0603-1582-58.
CODE Lot 22110 (sublots A,C,E) EXP 04/00 and lot 22227(sublots
A,C,E,F,H,K) EXP 06/00.
MANUFACTURER Morton Grove Pharmaceuticals, Inc., Morton
Grove, Illinois.
DISTRIBUTION Nationwide.
QUANTITY 10,618 4-ounce bottles and 29,038 16-ounce bottles
were distributed; firm estimated that less than 10 percent of the product
remained on market at time of recall initiation.
REASON Subpotency of the Promethazine Hydrochloride ingredient.
PRODUCT Triamcinolone Acetonide Cream USP, 0.1%,
in 15-gram tubes, Rx. NDC #49159-140-20.
CODE Lot #M793 EXP 3/03.
MANUFACTURER Thames Pharmacal Company, Inc., Ronkonkoma,
New York.
DISTRIBUTION Florida, California, Michigan, New York,
Georgia, Colorado, Connecticut, North Carolina, Arkansas, Hawaii.
QUANTITY 30,000 units were distributed.
REASON Mispackaging - Some of the tubes are incorrectly
labeled to contain Gentamicin Sulfate.
PRODUCT Dimethyl Sulfoxide, USP Grade DMSO (active
ingredient bulk), 500 mL and 1 liter amber glass bottles, Rx.
CODE Lot Numbers: USP990614, USP990727, and USP990817.
MANUFACTURER Gaylord Chemical Corporation, Bogalusa,
Louisiana.
DISTRIBUTION Nationwide and international.
QUANTITY 96 liters (232 pounds) of material in 500 mL
and 1-liter amber glass bottles were distributed.
REASON Package integrity/product leakage.
PRODUCT Lorazepam Injection, USP, 4 mg/ml, in 10
mL multiple dose vial (NDC #0074-1539-10) and 1 mL Carpujec(r)/needle prefilled
syringe (NDC #0074-1539-11), Rx for preanesthetic medication of adult patients
to produce sedation, relief of anxiety and a decreased ability to recall
events related to the day of surgery.
CODE Lot Numbers: 44-635-3B, 49-650-3B, 46-315-3A
MANUFACTURER Abbott Laboratories, Inc., McPherson, Kansas.
RECALLED BY Abbott Laboratories, Hospital Products Division,
Abbott Park, Illinois
DISTRIBUTION Nationwide.
QUANTITY 55,750 1-mL syringes and 2,392 10-mL vials were
distributed. Firm estimated that less than 5,000 -1-mL syringes and 1,500
10-mL vials remained on the market at time of recall initiation.
REASON Mislabeling - Incorrect drug concentration declared
(2 mg lorazepam). (Drug title correctly cites 4 mg/ml).
PRODUCT Tavist-D(r) Tablets, (Clemastine Fumarate,
USP 1.34 mg/ Phenylpropanolamine HCL 75mg), 8 tablet units, OTC, antihistamine/nasal
decongestant. NDC #0067-0122-08.
CODE Lot #306295 EXP 3/02.
MANUFACTURER Novartis Consumer Health, Inc., Lincoln,
Nebraska.
DISTRIBUTION Nebraska and Indiana.
QUANTITY 345,780 packages were distributed.
REASON Low weight tablets.
PRODUCT Morphine Sulfate Injection, USP, 10 mg/mL,
in 1 mL dosette(r) ampule, Rx potent analgesic. NDC #10019-178-68.
CODE Lot #099077 EXP 9/02.
MANUFACTURER ESI-Lederle, Cherry Hill, New Jersey.
RECALLED BY Baxter Pharmaceutical Products, Inc., New
Providence, New Jersey
DISTRIBUTION Nationwide.
QUANTITY 113,750 ampuls were distributed; firm estimated
that 3,657 ampuls remained on market at time of recall initiation.
REASON Mislabeled - Label incorrectly declares strength
as (1/8 gr per mL) not (1/6 gr per mL).
PRODUCT Urecholine(r) Injection (Bethanechol Chloride),
5.15 mg/mL, 1 mL injection, Rx for the treatment of acute post-operative/post-
partum non-obstructive urinary retention, and for neurogenic atony of urinary
bladder with retention. NDC #07786-29-00
CODE Lot Numbers: 0019E EXP 3/01, 0947E EXP 3/01, 0327J
EXP 8/01, 0346J EXP 8/01, 1323J EXP 8/01, 1324J EXP 8/01, 1374H EXP 8/01,
1606H EXP 8/01, 1898H EXP 8/01.
MANUFACTURER Merck and Company, Inc., West Point, Pennsylvania.
DISTRIBUTION Nationwide, France, Australia, Italy, Sweden,
Lebanon, South Africa.
QUANTITY 20,858 units were distributed; firm estimated
that 600 units remained on market at time of recall initiation.
REASON pH failure (at stability testing).
PRODUCT Lanoxin(r) Tablets (digoxin), 0.125mg,
in bottles of 1,000, Rx indicated for the treatment of mild to moderate
heart failure and for the control of ventricular response rate in patients
with chronic atrial fibrillation. NDC #0173-0242-075.
CODE Lot #9ZP1665 EXP 6/02.
MANUFACTURER Glaxo Wellcome, Inc., Zebulon, North Carolina.
DISTRIBUTION Alabama, Connecticut, Florida, Georgia,
Massachusetts, Maryland, Maine, Mississippi, New Jersey, New York, North
Carolina, Pennsylvania, South Carolina, Tennessee, Virginia, West Virginia,
Puerto Rico.
QUANTITY Firm estimated that 22,639 bottles remained
on market at time of recall initiation.
REASON Tablet thickness failure.
PRODUCT Digoxin Tablets, 0.125 mg, repacked in
unit dose blister packs (10x31) with and without a grid card, Rx indicated
for the treatment of mild to moderate heart failure, and for the control
of ventricular response rate in patients with chronic atrial fibrillation.
NDC #00615-0547-63 (uncarded) and NDC #00615-0547-53 (carded).
CODE Lot #0547-0003 EXP 1/31/01.
MANUFACTURER Glaxco Wellcome, Inc., Research Triangel
Park, North Carolina (responsible firm).
RECALLED BY NCS Health Care of KY, doing business as
Vangard Labs, Inc., Glasgow, Kentucky (repacker/distributor)
DISTRIBUTION Pennsylvania, Massachusetts, Illinois, New
York, Tennessee, North Carolina, California, Vermont, Maryland, Ohio, Maine.
QUANTITY 90 blister pack units were distributed.
REASON Tablet thickness failure.
PRODUCT Oxygen USP, Rx in E, D, and M-6 Compressed
Cylinders.
CODE E cylinders, coded 0260001 and 0260002 D cylinders,
coded 0260002; M-6 cylinders coded 0260002.
MANUFACTURER Southern Respiratory, Inc., Naples, Florida.
DISTRIBUTION Florida.
QUANTITY 21 E cylinders, 6 D cylinders and 3 M-6 cylinders
were distributed.
REASON Current good manufacturing deviations and complaint
related to "chlorine-like odor".
PRODUCT Vancomycin Hydrochloride, USP, Sterile,
10 g, in pharmacy bulk package, Rx for IV Infusion after dilution. NDC
#0469-3140-61.
CODE Lot Numbers: 180266, 180432, 180449, 180465, 180490,
180635, 180647, 180693.
MANUFACTURER American Pharmaceutical Partners, Inc.,
formerly known as Fujisawa USA, Melrose Park, Illinois.
RECALLED BY American Pharmaceutical Partners, Inc., Melrose
Park, Illinois
DISTRIBUTION Nationwide.
QUANTITY 44,006 100-mL vials were distributed. Firm estimated
that 20 percent of the product remained on market at time of recall initiation.
REASON Moisture failure during stability testing.
PRODUCT Estrostep(r) Fe Tablets, (norethindrone
acetate, ethinyl estradiol and ferrous fumarate), in 28 tablet dispensers,
Rx oral contraceptive. NDC #0071-0928-47
CODE Lot Numbers: 44808F EXP 3/00, 44908F EXP 3/00, and
44708F (Expired 2/00).
MANUFACTURER Warner Lambert, Fajardo, Puerto Rico.
RECALLED BY Parke-Davis, Division of Warner Lambert Company,
Morris Plains, New Jersey
DISTRIBUTION Nationwide.
QUANTITY 29,703 units were distributed; firm estimated
a minimal amount remained on market at time of recall initiation.
REASON Subpotency (at 12 month stability).