WEEK
ENDING OCTOBER 2
PRODUCT
Subutex (buprenorphine), 2 mg, 30 sublingual tablet, Rx only.
NDC 12496-1278-2.
CODE
Lot number 406401.
RECALLING FIRM/MANUFACTURER
Reckitt Benckiser Pharmaceut Inc., Richmond, VA.
REASON Mispackaging: Subutex 2 mg bottles contain Subutex 8 mg tablets.
VOLUME OF PRODUCT IN COMMERCE
3,750 bottles of 30 tablets.
DISTRIBUTION
Nationwide.
PRODUCT
a) BISOPROLOL FUMARATE TABLETS, 5 mg, Rx only, 30 Tablets (NDC 53489-555-07) and 100 Tablets
(NDC 53489-555-01).
b) BISOPROLOL FUMARATE TABLETS, 10 mg, Rx only, 30 Tablets (NDC 53489-556-07) and 100 Tablets
(NDC 53489-556-01).
CODE
a) Lot 50346 exp. 07/05, Lot 50347 exp. 07/05, and Lot 50348
exp. 07/05;
b) Lot 49257 exp. 07/05, Lot 49258 exp. 07/05, Lot 49731 exp.
10/05, and Lot 49732 exp. 10/05.
RECALLING FIRM/MANUFACTURER
Mutual Pharmaceutical Co., Inc., Philadelphia, PA.
REASON
Impurities/Degradation Products: The product exceeds limit for impurities.
VOLUME OF PRODUCT IN COMMERCE
3,799,160 tablets.
DISTRIBUTION
Nationwide.
PRODUCT
Zemuron Injection (rocuronium bromide), 10mg/5mL Injection, 5 mL Multidose Vials,
Box of 10, For IV use only, NDC 0052-0450-15.
CODE
Lot 3159804032 exp March 2006.
RECALLING FIRM
Organon USA Inc., West Orange, NJ.
REASON
Lack of Assurance of Sterility; three vials upstream of the filler were found
to contain a foreign liquid identified as Steris LpH SE
VOLUME OF PRODUCT IN COMMERCE
208,840 vials.
DISTRIBUTION
Nationwide.
PRODUCT
a) Phenytoin Oral Suspension, USP, 125 mg/5 mL, NDC 60432-131-
08.
b) Tannihist-12 RF Suspension, Carbetapentane Tannate 30 mg/5 mL
and Chlorpheniramine Tannate 4 mg/5mL, Rx only.
CODE
Lots 25020A, 25029A, 25426A, 25496A, 25499A, 25500A, 25544A,
25556A, 25625A, 25638A, 25700A, 25706A, 25776A, 25777A,
25813A, 25820A, 25898A, 25899A, 25900A, 25962A, 25963A,
25974A, 26017A, 26021A, 26026A, 26058A, 26061A, 26094A,
26106A, 26108A, 26201A, 26312A, 26314A, 26385A, 26446A,
26448A, 26484A, 26486A, 26491A, 26508A, 26511A, 26532A,
26536A, 26596A, 26601A, 26604A, 26618A, 26620A, 26639A,
26642A, 26676A, 26680A, 26683A;
b) Lot Numbers: 4 oz. lots 25203A, 25328A, 25428A, 25486A,
25561A, 26039A, 25689A, 26083A, 26140A, 25822A, 25854C,
26412A 16 oz. lots 25205A, 25313A, 25754A, 25903A, 25904A,
26466A.
RECALLING FIRM/MANUFACTURER
Morton Grove Pharmaceuticals, Inc., Morton Grove, IL.
REASON Superpotent: Super-potency of the active ingredient.
VOLUME OF PRODUCT IN COMMERCE
555,225 bottles.
DISTRIBUTION
Nationwide.
PRODUCT
Potassium Chloride Extended Release Tablets USP, 1500 mg, 20 mEq K, 100 and
500 tablet bottles, Rx ONLY, Manufactured by Andrx Pharmaceuticals, Inc., Fort
Lauderdale, FL 33314 NDC 62037-720-01.
CODE
Lot Numbers: 720D054 (100's), 720D052, 720D057 and 720D002 (500's), Expiration
Date Oct-05.
RECALLING FIRM/MANUFACTURER
Andrx Pharmaceuticals, Inc., Davie, FL.
REASON
Dissolution Failure (4 hour timepoint).
VOLUME OF PRODUCT IN COMMERCE
4,396, 400 Tablets.
DISTRIBUTION
Nationwide.
PRODUCT
Tartaric Acid, NF. Product size configuration: 250 gram bottle.
CODE
Item # TX0016-1 Lot # TM0324.
RECALLING FIRM/MANUFACTURER
EMD Chemicals Inc., Gibbstown, NJ.
REASON
One lot of Tartaric Acid, NF is out of specification for sulfate.
VOLUME OF PRODUCT IN COMMERCE
33 bottles.
DISTRIBUTION
Nationwide and Canada.
PRODUCT
Senokot (standardized senna concentration) Tablets, 8.6 sennosides, 50 count
bottles, NDC 0034-1200-50.
CODE
Lot 7C21 exp. 8/31/05.
RECALLING FIRM/MANUFACTURER
The Purdue Frederick Company, Stamford, CT.
REASON Mispackaging: Two orange Senokot-S tablets found within a bottle of Senokot
Tablets (brown tablets).
VOLUME OF PRODUCT IN COMMERCE
72,492 bottles
DISTRIBUTION
Nationwide.
WEEK ENDING OCTOBER 9
PRODUCT
Spironolactone Tablets, 25mg, blister packages of 30 tablets, Rx
only, NDC 61392-083-30.
CODE
Lot #U31990B30.
RECALLING FIRM/MANUFACTURER
Heartland Repack Services, Llc, Toledo, OH.
REASON Mispacked; Two unit dose strips of Furosemide 40mg tablets were found in a unit dose box of Spironolactone 25mg tablets.
VOLUME OF PRODUCT IN COMMERCE
1,343/30 count boxes.
DISTRIBUTION
OH, IN, TN, KY, WA, and MD.
PRODUCT
Isopropyl Rubbing Ethyl Alcohol 70%, First Aid Antiseptic, 16 Fl oz, NDC 0395-4201-16.
CODE
Lot Numbers: 19138, 19168.
RECALLING FIRM/MANUFACTURER
Aaron Industries Inc., Lynwood, CA.
REASON
Mislabeling; product label incorrectly identifies the product as “isopropyl Rubbing Ethyl Alcohol 70%” instead of “Rubbing Alcohol Ethyl Alcohol 70%”.
VOLUME OF PRODUCT IN COMMERCE
8,240.
DISTRIBUTION
Nationwide.
PRODUCT
Diltiazem Hydrochloride Extended Release Capsules, 120 mg, Rx only, 90 capsules, NDC 0093-5112-98.
CODE
Lot number 0303T01 exp 10/05.
RECALLING FIRM/MANUFACTURER
Teva Pharmaceuticals, Sellersville, PA.
REASON
Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE
1,437 bottles.
DISTRIBUTION
Nationwide.
PRODUCT
OxyContin Tablets (oxycodone hydrochloride controlled release), 20mg, 100 tablets, Rx only, Distributed by: Purdue
Pharma, L.P., Norwalk, CT 06850-3590, NDC 59011-103-10.
CODE
Lot 8R2NI Exp. 10/04.
RECALLING FIRM/MANUFACTURER
The Purdue Frederick Company, Stamford, CT.
REASON Mispackaging: One OxyContin 10mg tablet was found within a previously unopened OxyContin 20mg tablet bottle.
VOLUME OF PRODUCT IN COMMERCE
10,285 bottles.
DISTRIBUTION
Nationwide.
WEEK ENDING OCTOBER 16
PRODUCT
Protonix I.V. for Injection (pantoprazole sodium) Equivalent to
40 mg pantoprazole per vial, 10 cartons per vial, For I.V.
Infusion only, Rx only, NDC 0008-0923-51.
CODE
Lot number 14047A exp. 3/06, Lot number 14048A exp. 3/06, Lot number 14049A
exp. 3/06, Lot number 14050A exp. 3/06, Lot number 14051A exp. 3/06, Lot number
14052A exp. 3/06, Lot number 14053A exp. 3/06, Lot number 24056A exp. 4/06,
Lot number 24057A exp. 4/06, Lot number 24059A exp. 4/06, and Lot number 24060A
exp. 4/06.
RECALLING FIRM/MANUFACTURER
Wyeth Pharmaceuticals, Philadelphia, PA.
REASON
Lack of Assurance of Sterility due to loose seal caps on vials (manufacturer).
VOLUME OF PRODUCT IN COMMERCE
41,282 vials.
DISTRIBUTION
Nationwide and Guam.
PRODUCT
BETCO brand E-2 Food Industry Hand Cleaner, (Benzalkonium Chloride) 2.5%, Hand
Washing Sanitizer, Net Contents 30.4 fl. oz. (U.S./E.U.) 900 mL, 84 oz (U.S./E.U.)
2500mL, and 1 gallon (U.S./E.U.) 3.78L size containers, ---- Also produced under
the private brand name Northwoods Germ Stuff, and CleanChoice Food Industry
Hand Cleaner/Sanitizer.
CODE
1634, 1644, 1664, 1674, 1684, 1694, 1704, 1714, 1734, 1744, 1754, 1764, 1774,
1784, 1804, 1814, 1824, 1834, 1844, 1854, 1874, 1884, 1894, 1904, 1914, 1924,
1944, 1954, 1964, 1974, 1984, 1994, 2014, 2024, 2034, 2044, 2054, 2064, 2084,
2094, 2104, 2114, 2124, 2134, 2154, 2164, 2174, 2184.
RECALLING FIRM/MANUFACTURER
Betco Corp. Ltd, Toledo, OH.
REASON
Bacterial contamination (photobacterium logei).
VOLUME OF PRODUCT IN COMMERCE
72/gallon size containers, 22/900 mL containers, and 31/2500 mL containers.
DISTRIBUTION
Nationwide.
PRODUCT
a) CombiPatch 50/140 Transdermal Patch, stradiol/norethindrone
acetate transdermal system, 0.05/0.14 mg per day, Rx
contraceptive patch, 8 patches per box, 3 boxes per case,
NDC 0078-0377-42, Walgreen item 673868.
b) CombiPatch 50/250 Transdermal Patch, stradiol/norethindrone
acetate transdermal system, 0.05/0.25 mg per day, Rx
contraceptive patch, 8 patches per box, 3 boxes per case,
NDC 0078-0378-45, Walgreen item 673705.
c) Bausch & Lomb Desmopressin Acetate Nasal Solution, 0.01%, 5
mL bottle with spray attachment, delivering 0.1 mL per
actuation, Rx antidiuretic hormone, NDC 24208-342-05,
Walgreen item 675618.
d) Erythromycin Ethylsuccinate Oral Suspension, USP, 200 mg/5 mL, one pint bottle, Rx, NDC 0074-3747-16, Walgreen item
677076.
e) Erythromycin Ethylsuccinate Oral Suspension, USP, 400 mg/5 mL, one pint bottle, Rx, NDC 0074-3748-16, Walgreen item
677077.
f) Ethezyme 830 Papain-Urea Debriding Ointment, 8.3 x 105 units papain, 100 mg Urea, 30 g tube, Rx only, NDC 58177-816-02,
Walgreen item 676517.
g) Foradil Aerolizer, formoterol fumarate inhalation powder, 12
mcg capsules, 12 and 60 capsule blister pack w/aerolizer
inhaler, Rx only, , NDC 0085-1401-01, Walgreen item 676713.
h) Leuprolide Acetate Injection, 1 mg/0.2 mL leuprolide acetate,
Rx only, 2.8 mL vial in 14 day patient administration kit,
NDC 0185-7400-85, Walgreen item 680339.
i) Miacalcin Nasal Spray, calcitonin-salmon nasal solution, 30
dose bottle, 200 I.U. calcitonin-salmon per 0.09 mL spray
dose, 3.7 mL bottle, Rx only, NDC 0078-0311-54, Walgreen item 672454.
j) NuvaRing Etonogestrel/Ethinyl Estradiol Vaginal Ring,
delivers 0.120 mg etonogestrel and 0.015 mg ethinyl estradiol
per day for 3 weeks, Rx only, 1 ring sachet per box, NDC
0052-0273-01, Walgreen item 680703.
k) Orapred Oral Solution, 20.2 mg/5mL prednisolone sodium
phosphate equivalent to 15 mg prednisolone base, Rx only,
8 fl. oz. (237 mL) bottle, NDC 59439-455-02, Walgreen item 680765.
l) G & W Promethegan (Promethazine HCl Suppositories, USP), 12.5
mg., 12 suppositories per box, Rx only, NDC 0713-0536-12,
Walgreen item 682540.
m) G & W Promethegan (Promethazine HCl Suppositories, USP), 25
mg., 12 suppositories per box, Rx only, NDC 0713-0526-12,
Walgreen item 684051.
n) Promethazine HCl Suppositories, USP, 50 mg., 12 suppositories
per box, Rx only, NDC 53265-764-12, Walgreen item 683099.
o) Falcon Trifluridine Ophthalmic Solution 1%, 7.5 mL
bottle, Rx only, NDC 61314-044-75, Walgreen item 684644.
p) Regular Human Insulin Injection (rDNA origin) U-100, 100 units/mL, OTC, 10 mL vials, distributed under the following
labels:
a) Humulin R Regular Human Insulin Injection, USP, HI-210, NDC 0002-8215-01, Walgreen item 676095
b) Novolin R
Regular Human Insulin Injection, NDC 0169-1833-11, Walgreen
item 681247.
q) NPH Human Insulin (rDNA origin) Isophane Suspension, U-100,
100 units/mL, OTC, distributed under the following labels and
containers:
a) Humulin N NPH Human Insulin
(rDNA origin)
Isophane Suspension, HI-310, 10 mL vials, NDC 0002-8315-01,
Walgreen item 676096;
b) Humulin N Pen, 5 x 3 mL Disposable Pen Insulin Delivery Devices, HP-8730, NDC 0002-8730-59, Walgreen item 681596;
c) Novolin N NPH Human Insulin Isophane Suspension (rDNA origin),10 mL vials, NDC 0169-1834-11, Walgreen item 681245;
d) Novolin N
PenFill, 5 x 3 mL
cartridges for use with NovoPen 3 Insulin Delivery Device,
NDC 0169-3474-18, Walgreen item 681008.
r) 70% Human Insulin Isophane Suspension 30% Human Insulin
Injection (rDNA origin), U-100, 100 units/mL human insulin,
OTC, distributed under the following labels and containers:
a) Humulin 70/30, HI-710, 10 mL vials, NDC 0002-8715-01,
Walgreen item 678064,
b) Humulin 70/30 Pen, 5 x 3 mL Disposable Pen Insulin Delivery Devices, HP-8770, NDC 0002- 8770-59, Walgreen item 680333,
c) Novolin 70/30, 10 mL vials, NDC 0169-1837-11, Walgreen item 679253,
d) Novolin 70/30 InnoLet Insulin Pen, 5 x 3 mL pre-filled disposable insulin dosers, Walgreen item 672061,
e) Novolin 70/30
PenFill, 5 x 3
mL cartridges for use with NovoPen 3 Insulin Delivery Device,
NDC 0169-3477-18, Walgreen item 681599.
s) Humulin 50/50, 50% Human Insulin Isophane Suspension 50%
Human Insulin Injection (rDNA origin), U-100, 100 units/mL
human insulin, OTC, HI-1510, 10 mL vials, NDC 0002-9515-01,
Walgreen item 677858.
t) Humulin L Lente Human Insulin (rDNA origin) Zinc Suspension,
70% crystalline and 30% amorphous insulin suspension, 100 units/mL human insulin
(rDNA), OTC, HI-410, 10 mL vials, NDC
0002-8415-01, Walgreen item 678097.
u) Humulin U Ultralente Human Insulin (rDNA origin) Extended
Zinc Suspension, U-100, 100 units/mL human insulin, OTC, HI-
610, 10 mL vials, NDC 0002-8615-01, Walgreen item 681349.
v) Humalog Insulin Lispro Injection (rDNA origin), U-100, 100 units/mL human insulin, Rx, distributed in the following
containers:
a) Humalog, 10 mL vials, VL-7510, NDC 0002-7510- 01, Walgreen item 673093
b) Humalog Pen, 5 x 3 mL Disposable
Insulin Delivery Devices, HP-8725, NDC 0002-8725-59, Walgreen
item 680332.
w) Humalog Mix 75/25, 75% Insulin Lispro Protamine Suspension
25% Insulin Lispro Injection (rDNA origin), U-100, 100 units/mL human insulin, Rx, distributed in the following
containers:
a) Humalog Mix 75/25, 10 mL vial, VL-7511, NDC 0002-7511-01, Walgreen item 676801
b) Humalog Mix 75/25 Pen,
5 x 3 mL Disposable Insulin Delivery Devices, HP-8794, NDC
0002-8794-59, Walgreen item 677240.
x) Novolog Insulin Aspart Injection (rDNA origin), U-100, 100 units/mL human insulin, Rx, distributed in the following
containers:
a) Novolog, 10 mL vials, NDC 0169-7501-11, Walgreen item 680728
b) Novolog PenFill, 5 x 3 mL PenFill cartridges for use with NovoPen 3, insulin delivery devices, NDC 0169-3303-12, Walgreen item 675572
c) Novolog Flexpen
Prefilled Syringe, 5 x 3 mL pre-filled insulin syringes, NDC
0169-6339-10, Walgreen item 680670.
y) Novolog Mix 70/30, 70% Insulin Aspart Protamine Suspension
and 30% Insulin Aspart Injection, (rDNA origin), U-100, 100 units/mL human insulin, Rx only, distributed in the following
containers:
a) Novolog Mix 70/30,10 mL vial, NDC 0169-3685- 12, Walgreen item 675106
b) Novolog Mix 70/30 PenFill, 5 x 3 mL PenFill cartridges for use with 3 mL PenFill cartridge compatible delivery devices, NDC 0169-3682-13, Walgreen item 675491
c) Novolog Mix 70/30 FlexPen Prefilled Syringe, 5 x 3
mL pre-filled insulin syringes, NDC 0169-3696-19, Walgreen
item 675492.
CODE
Shipment numbers 0485217 through 0485373, all processed on 8/13/04 and shipped
on 8/16/04.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Walgreen Company, Deerfield, IL.
REASON
Inadvertent distribution of refrigerated drugs which had been subject to a two
day power outage resulting from hurricane Charley.
VOLUME OF PRODUCT IN COMMERCE
604 vials, 120 bottles, 163 vials, 6 tubes, 127 blister packs, 60 pens, 10 syringes.
DISTRIBUTION
Nationwide.
PRODUCT
Pegaspargase Oncaspar (PEG-L-asparaginase), 750 I.U. per mL, one 5.0 mL single
dose vial, Sterile, For intramuscular use only, Contains no preservative, Rx
only, NDC 57665-002-02.
CODE
Lot AG0314 Exp. 9/17/2005.
RECALLING FIRM/MANUFACTURER
Enzon Pharmaceuticals, Inc., South Plainfield, NJ.
REASON Superpotent; product exceeds enzyme levels (9 month stability).
VOLUME OF PRODUCT IN COMMERCE
2,184 vials.
DISTRIBUTION
Nationwide, Canada, Australia and New Zealand.
WEEK ENDING OCTOBER 23
PRODUCT
Spectrum Purified Water (Distilled Water) USP, 20L and 200L
containers, For manufacturing, processing or repacking. Not
sterile.
CODE
Lot numbers: ST1136, SI0041, SU0227, SI0897, SI1226, SW0169, TM0905, TO0079,
TC0516, TP0214, TD0594, TQ0018, TQ0010, TE0282, TQ0447, TQ0674, TF0423.
RECALLING FIRM/MANUFACTURER
Spectrum Laboratory Products, Inc., Gardena, CA.
REASON
Microbial contamination; burkholderia cepacia.
VOLUME OF PRODUCT IN COMMERCE
537.
DISTRIBUTION
Nationwide and PR.
PRODUCT
Apria Healthcare, Oxygen, Compressed USP, B size aluminum high pressure gas
cylinder, UN1072, Rx only..
CODE
Lot CE01R189B C = Airgas Intermountain, E = Idaho Falls, 01 = Number of bulk
medical oxygen received in a month, R = corresponds to the year (2004), 189
= Julian date (July 7), B = second fill (batch) of the day.
RECALLING FIRM/MANUFACTURER
Apria Healthcare, Inc., Idaho Falls, ID.
REASON
Cylinder contaminated with carbon tetrafluoride.
VOLUME OF PRODUCT IN COMMERCE
47 cylinders.
DISTRIBUTION
ID.
PRODUCT
Oxygen, Cryogenic liquid in bulk form, converted to gas.
CODE
Lot number: 264MERA04022B.
RECALLING FIRM/MANUFACTURER
Praxair Inc., Danbury, CT.
REASON
Manufacturer not registered with FDA for the production of medical Oxygen, Industrial
grade Oxygen delivered to medical facilities.
VOLUME OF PRODUCT IN COMMERCE
700,200 Cubic feet.
DISTRIBUTION
FL.
WEEK ENDING OCTOBER 30
PRODUCT
Ephedrine Sulfate Injection, USP, 50 mg/mL, 10 mL Vial, For SC, IM or IV Use,
Preservative Free, Pharmacy Bulk Package for Pharmacy Use Only, Rx Only, NDC
Number: 66758-009-01.
CODE
Lot No: 012704.
RECALLING FIRM/MANUFACTURER
Parenta Pharmaceuticals, West Columbia, SC.
REASON
Sterility Failure.
VOLUME OF PRODUCT IN COMMERCE
83 vials.
DISTRIBUTION
FL, and SC.
PRODUCT
a) EMD Chemicals Inc. Brand MultiPharm Water, Purified, USP/Ph Eur, 10L
Cubitainer, Not for Injection, Caution:
For Manufacturing, Processing, or Repacking.
b) EMD Chemicals Inc. Brand MultiPharm Water, Purified, USP/Ph Eur, 20L Cubitainer and 20L Poly Drum, Not for
Injection.
c) EMD Chemicals Inc. Brand MultiPharm Water, Purified, USP/Ph Eur, 50L Poly Drum, Not for Injection, Caution:
For Manufacturing, Processing, or Repacking.
d) EMD Chemicals Inc. Brand MultiPharm Water, Purified, USP/Ph Eur, 200L Poly Drum, Not for Injection, Caution:
For Manufacturing, Processing, or Repacking.
CODE
a) Item# WX0006/2 -- 10L cubitainer: Lot: 3220; 3259;
4031; 4110;
b) Item# WX0006/3 -- 20L cubitainer: Lot: 3220; 3246A;
3259; 3300; 3325; 4020; 4031; 4040; 4050; 4110;
4130; 4150; 4198.
Item# WX0006/4 -- 20L poly drum: Lot: 3259; 3300;
4040; 4050;
c) Item # WX0006/5 -- 50L poly drum: Lot: 3220; 3230;
3300; 4031; 4040; 4050; 4080; 4110;
d) Item # WX0006/30 -- 200L poly drum: Lot: 3200; 3230;
3246; 3305; 3315; 3320; 3339; 3345; 4020; 4030; 4035;
4036; 4041; 4045; 4070; 4089; 4115; 4137; 4200.
RECALLING FIRM/MANUFACTURER
Emd Chemicals Inc., Gibbstown, NJ.
REASON
Microbial Contamination; burkholderia cepacia.
VOLUME OF PRODUCT IN COMMERCE
5,724 units.
DISTRIBUTION
Nationwide.
PRODUCT
ACEONÆ Tablets, (perindopril erbumine), 2 mg, 100 count bottles, Rx only, NDC
0032-1101-01.
CODE
Lot 3029632, Exp. 1/31/2005, 3029633, Exp. 1/31/2005, 3031235, Exp. 4/30/2005,
3031236, Exp 4/30/2005, 3032691, exp. 7/31/2005.
RECALLING FIRM/MANUFACTURER
Solvay Pharmaceuticals, Inc., Marietta, GA.
REASON
Degradation Failure.
VOLUME OF PRODUCT IN COMMERCE
22,287 bottles.
DISTRIBUTION
Nationwide and PR.
PRODUCT
a) Tiazac (diltiazem HCl) 300 mg capsules, 30, 90 and
1000 count bottles, Rx only, NDC 0456-2615-10.
b) Tiazac (diltiazem HCl) 120 mg capsules, 30, 90 count
bottles, Rx only, NDC 0456-2612-90.
c) Tiazac (diltiazem HCl) 180 mg capsules, 30, and 1000
count bottles, Rx only, NDC 0456-2613-10.
d) Tiazac (diltiazem HCl) 240 mg capsules, 30 count
bottle, Rx only, NDC 0456-2614-30.
e) Tiazac (diltiazem HCl) 360 mg capsules, 90 count
bottle, Rx only, NDC 0456-2616-90. ;
f) Tiazac (diltiazem HCl) 420 mg capsules, 30 and 90
count bottle, Rx only, NDC 0456-2617-90.
CODE
a) Lot no./Exp. date: 010203 (1/2005), P030410 (3/2007),
P030420 (3/2007), P030801 ( 6/2007);
b) Lot no. Exp. date P030906 5/2007, P030606 5/2007;
c) Lot no. Exp. date P03A008 12/2006, P03A018 12/2006,
030302 02/2007;
d) Lot no. Exp. date P030411 3/2007;
e) Lot no. Exp. date P030411 3/2007;
f) Lot no. Exp. date P030516 4/2005, P030902 8/2005,
P030811 5/2005, P030808 5/2005.
RECALLING FIRM/MANUFACTURER
Biovail Laboratories, Inc., Carolina, PR.
REASON
Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE
27,240.
DISTRIBUTION
Nationwide.
PRODUCT
Pharmacist Formula, Enteric Coated Aspirin Tablets, 325 mg, 100 count bottles,
OTC.
CODE
Lot Numbers: 2HA0359, 2HA0629, 2MA0356, 2MA0694.
RECALLING FIRM/MANUFACTURER
Leiner Health Products Llc, Carson, CA.
REASON
Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE
25,114 bottles.
DISTRIBUTION
Nationwide.
PRODUCT
a) Diltiazem Hydrochloride Extended-Release Capsules, USP, 120 mg, 90 count bottle, Rx only,
NDC 0093-5112-98.
b) Diltiazem Hydrochloride Extended-Release Capsules, USP, 180 mg, 90 count bottle, Rx only, NDC 0258-
3688-90.
c) Diltiazem Hydrochloride Extended-Release Capsules, USP, 300 mg, 90 count bottle, Rx only, NDC 0258-
3690-90.
CODE
a) Lot No. 0303T01, Exp. date 10/2005;
b) Lot No. P03579, Exp. date 11/2004;
c) Lot No, P030602.
RECALLING FIRM/MANUFACTURER
Biovail Laboratories, Inc., Carolina, PR.
REASON
Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE
34,786.
DISTRIBUTION
Nationwide.