APRIL 2003

WEEK ENDING APRIL 5

PRODUCT Lanoxin (digoxin) Elixir Pediatric, 50 mcg (0.05 mg), 60 ml bottle, Rx only.
CODE Lot numbers: 1G605, 1F716, 1G608, 1H622, 1K618, 2D604, 2G704, and 2H602.
RECALLING FIRM/MANUFACTURER Recalling Firm: SmithKline Beecham Corp., Zebulon, NC

REASON Product contains brown cardboard particles.
VOLUME OF PRODUCT IN COMMERCE 282,850 units.
DISTRIBUTION Nationwide.

PRODUCT Terazosin Hydrochloride Capsules, 1 mg, 500 count bottles, Rx only.
CODE Lot number 4336-707 Exp. Date Jun 03.
RECALLING FIRM/MANUFACTURER Recalling Firm: IVAX Pharmaceuticals, Miami, FL,.
Manufacturer: Zenith Goldline Pharmaceuticals, Inc.
REASON Dissolution Failure; 18 month timepoint (stability).
VOLUME OF PRODUCT IN COMMERCE 50 bottles.
DISTRIBUTION Nationwide.

PRODUCT
a) Acyclovir Tablets, USP, 400 mg, 100 tablet bottles, Rx only.
b) Metformin Hydrochloride Tablets, 1000 mg, 500 tablet bottles, Rx only.

CODE
a) Lot 553C21 Exp. 4/04;
b) Lot 438F21 Exp. 7/04.
RECALLING FIRM/MANUFACTURER Alpharma Purepac, Elizabeth, NJ,.
REASON
a) Tablets contain fibers;
b) Product may contain iron/zinc particles.
VOLUME OF PRODUCT IN COMMERCE
a) 16,482 bottles;
b) 1,970 bottles.
DISTRIBUTION Nationwide.

PRODUCT MD-Gastroview, (Diatrizoate Meglumine 660mg and Diatrizoate Sodium 100mg, Injection, USP), 120mL amber glass, screw cap bottles, 367mg/mL Organically Bound Iodine, Rx only. For Gastrointestinal radiography, Not For Parenteral Use.
CODE Lot numbers E009A and E026A.
RECALLING FIRM/MANUFACTURER Tyco Healthcare, Raleigh, NC,.
REASON Misbranded; incorrectly labeled Diatrizoate Meglumine, Diatrizoate Sodium Injection rather than Diatrizoate Meglumine, Diatrizoate Sodium Solution.
VOLUME OF PRODUCT IN COMMERCE
3138 cases of lot E009A; 3134 cases of lot E026A.
DISTRIBUTION Nationwide, Argentina and Costa Rica.

PRODUCT Oleic Acid, NF/FCC, (Clear), Class IIIB, 500 mL bottles.
CODE Lot Number 022851.
RECALLING FIRM/MANUFACTURER Fisher Scientific Group, Somerville, NJ,.
REASON Contamination; product contains yeast.
VOLUME OF PRODUCT IN COMMERCE 400 bottles.
DISTRIBUTION Nationwide.

PRODUCT Strattera Capsules (atomoxetine HC1) 40mg, 24 count bottle, Rx only, Adult Sample Pack.
CODE 6AE95B.
RECALLING FIRM/MANUFACTURER Eli Lilly and Company, Indianapolis, IN,
REASON Misbranded; bottle label is incorrectly printed as "First use blister".
VOLUME OF PRODUCT IN COMMERCE 89,360 bottles.
DISTRIBUTION Nationwide.

PRODUCT Doryx Capsules (coated doxycycline hyclate pellets) 75mg, 6 blisterpack physician samples (2 tablets each) and 60 count bottles, Rx only.
CODE Lot numbers: 60 tablet bottles 60722662 Exp. 10/03; 60722690 Exp. 10/03; 60722663 Exp. 10/03. Lot numbers: Physician Samples unit dose (Blisters) 60725446 Exp. 10/03; 60725446A Exp. 10/03; 60735786 Exp. 12/03; 60735786A Exp. 12/03; 1896 Exp. 3/03.
RECALLING FIRM/MANUFACTURER Recalling Firm: Warner Chilcott Labs, Rockaway, NJ,
Manufacturer: Faulding Pharmaceutical/DBL, a division of F. H. Faulding & Co., Limited, Salisbury, South Australia.

REASON Lack of assurance of stability throughout labeled expiration.
VOLUME OF PRODUCT IN COMMERCE 51,858 bottles; 174,541 blisters.
DISTRIBUTION Nationwide.

PRODUCT Drituss GP Tablets, (Guaifenesin 1200mg and Pseudoephedrine hydrochloride 120mg) 100 count bottles, Long-Acting, Dye-Free, Rx only

CODE Lot numbers: 025L2A, 023L2A, 024L2A, 016B2RA, 015B2A, 003L1A, 010F2A.
RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals LLC, Huntsville, AL,

REASON Failure to validate manufacturing process.
VOLUME OF PRODUCT IN COMMERCE 18,499 bottles of 100 tablets.
DISTRIBUTION Nationwide.

PRODUCT Diltiazem CD Capsules (Diltiazem hydrochloride Extended-Release Capsules, USP) 180 mg, 90 capsule bottles, (Once-a-Day Dosage), Rx only.
CODE Lot 725D21 Exp 3/04; Lot 726D21 Exp 3/04; Lot 727D31 Exp 3/04; Lot 728D21 Exp 1/04.
RECALLING FIRM/MANUFACTURER Alpharma Purepac, Elizabeth, NJ,.
REASON Failure to validate a reduced batch size manufacturing process.
VOLUME OF PRODUCT IN COMMERCE 33,005 bottles.
DISTRIBUTION Nationwide.

PRODUCT Kytril Tablets (granisetron HC1), 1mg, 2 tablet unit of use package and 20 tablet single unit package, Rx only.
CODE Blister of 20 tablets: Lot numbers 029055 Exp. 4/2003; 029056 Exp. 4/2003; 036198 Exp. 3/2005; 036199 exp. 3/2005;
036200 Exp. 3/2005; 039142 Exp. 7/2005; Blister of 2 tablets: Lot number 028107 Exp. 4/2003.
RECALLING FIRM/MANUFACTURER Hoffmann LaRoche, Inc., Nutley, NJ,.
REASON Mispackaged; blistercard incorrectly contains two tablets rather than one tablet.
VOLUME OF PRODUCT IN COMMERCE 64,073 packages.
DISTRIBUTION Nationwide.

ULTRA HEALTH LABORATORIES, INC. AND BIONATE INTERNATIONAL, INC. WARN CONSUMERS AGAINST TAKING THEIR DIETARY SUPPLEMENT PRODUCT WITH THEIR VOLUNTARY RECALL OF VINAROL TABLETS

Ultra Health Laboratories, Inc. and Bionate International, Inc. are warning consumers not to purchase or consume a product known as Vinarol tablets. This product, which is being marketed as a dietary supplement, contains the unlabeled prescription drug ingredient, sildenafil, which may pose possible serious health risks to some users. Vinarol is marketed in tablet form in blister packages of 2 and 7 tablets and is labeled as distributed by Ultra Health Laboratories, Inc. and/or Bionate International, Inc. The product is being promoted for increasing desire, confidence and sexual performance and is sold over the counter, as well as, via the Internet.

The interaction between nitrates and sildenafil can result in profound and life-threatening lowering of blood pressure. The use of nitrates in any form is an absolute contraindication for sildenafil users. The potential for this product to be taken by unknowing nitrate users is real, since erectile dysfunction is often a concurrent condition in patients with diabetes, hypertension, hyperlipidemia, smokers and patients with ischemic heart disease.

Consumers who have purchased Vinarol tablets are urged to immediately discontinue their use and return them to their place of purchase or directly to Ultra Health Laboratories, Inc. at 3249 East Harbour Drive, Phoenix, Arizona 85034. Purchasers with questions regarding this recall may contact the company toll free at 1-800-796-1150. Consumers who have used this product and have medical concerns should consult with their health care providers.

WEEK ENDING APRIL 12

PRODUCT
a) Methylprednisolone Acetate Injection, 40mg/mL P.F.,Preservative Free, Single Dose Vial, sold in 1ml, 2ml, 5ml, or 10ml vials.
b) Methylprednisolone Acetate Injection, 80mg/mL, Preservative Free, Single Use Vial, sold in 1ml, 2ml, 5ml, or 10ml vials.
CODE
a) 28022002:03 02012002:56 24012002:95 05022002:11 21022002:91 04042002:29 01052002:01 07052002:06 09052002:33 14082002:59 19092002:45;
b) 4667:47A, 4667:47B, 4667:47C : 02012002:30 22012002:71 29012002:38 08022002:79 13022002:59 16022002:12 22022002:89 28022002:09 12032002:39 19032002:09 04042002:32 30042002:35 07052002:20 09052002:75 14052002:70 03062002:58 20062002:32 06082002:46
22082002:37 03092002:79 23092002:29 4651:14 4750:65 4775:88.
RECALLING FIRM/MANUFACTURER Lee Pharmacy, Inc., Fort Smith, AR,

REASON
a) Microbial contamination;
b) Fungal contamination (Cladosporium).
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Nationwide.

PRODUCT
a) Betamethasone Injection Repository P.F. 6mg, Preservative Free, Single Dose Vial, sold in 1ml, 2 ml,5ml, or 10ml vials.
b) Betamethasone Sodium Phosphate Injection, Preservative Free, 12mg/mL, Single Dose Vial, sold in 1ml, 2 ml, 5ml, or 10ml vials.
c) Bupivacaine 0.25% Injection, Preservative Free, Single Dose Vial, sold in 1ml, 2 ml, 5ml, or 10ml vials.
d) Clonidine Hydrochloride Injection, 100mg, Preservative Free, Single Dose Vial, Lee Pharmacy, Inc., 4300 Grand Avenue, Fort Smith, AR 72904, sold in 1ml, 2 ml, 5ml, or 10ml vials.
e) Co-Enzyme Q-10 Injection, Preservative Free, Single Dose Vial, sold in 1ml, 2 ml, 5ml, or 10ml vials.
f) EDTA 150 mg/ml injection, 100 ml, Preservative Free.
g) Hyaluronidase 150U/ml injection, Preservative Free, Single Dose Vial, sold in 1ml, 2 ml, 5ml, or 10ml vials.
h) Sodium Chloride 23.4% Injection, Preservative Free, Single Dose, sold in 1ml, 2 ml, 5ml, or 10ml vials.
i) Sodium Chloride 10% Injection, Preservative Free, Single Dose Vial, sold in 1ml, 2 ml, 5ml, or 10ml vials.
j) Sodium Chloride 3% Injection, Preservative Free, Single Dose Vial, sold in 1ml, 2 ml, 5ml, or 10ml vials.
k) Triamcinolone Acetonide Injection, 40mg/ml P.F., Preservative Free, Single Dose Vial, sold in 1ml, 2 ml, 5ml, or 10ml vials.
l) Triamcinolone Diacetate,40 mg/ml P.F., Preservative Free, Single Dose Vial, sold in 1ml, 2 ml, 5ml, or 10ml Vials.
m) Betamethasone LA-SA, Injection, 12mg/ml, Preservative Free, Single Dose Vial, sold in 1ml, 2 ml, 5ml, or 10ml Vials.
CODE
a) 19022002:71; 20022002:02; 02042002:65; 14052002:50; 21052002:19; 10062002:14; 09072002:20; 29072002:12; 30072002:22; 20082002:27; 09092002:81; 4642:76; 4678:46; 4706:40; 4755:77; 4786:27; 4831:25; 4850:25; 11032002:24; 4848:35; 02072002:23;
b) 13062002:46; 27082002:15; 4722:37; 4702:55; and 4721:33;
c) 23012002:98 02042002:40 12062002:79 22082002:45 4742:96;
d) 14082002:42 20092002:39 4663:40;
e) 15022002:08;
f) 21082002:24 4645:62 4761:84;
g) 22082002:88 16092002:28;
h) 4746:25;
i) 4714:50;
j) 4690:43;
k) 20062002 25042002:64 03062002:38 02072002:58 02082002:31 27082002:21 09092002:88 4737:75;
l) 05022002:48 11022002:43 11032002:55 21032002:41 15042002:44 25042002:54 20052002:71 29052002:19 30052002:54;
m) 14052002:65.
RECALLING FIRM/MANUFACTURER
Lee Pharmacy, Inc., Fort Smith, AR,.
REASON Lack of assurance of sterility.
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Nationwide.

PRODUCT
a) Betamethasone LA-SA 6mg/mL Multi-Dose Vial, Not for IV Administration, Use By 11/03. .
b) Betamethasone SA-LA 6mg/ml P.F., 5mL Single Dose Vial, Preservative Free, Not for IV Administration, Use By 11-03.
CODE
a) Lot 4785:43A;
b) Lot 4786:27B.
RECALLING FIRM/MANUFACTURER Lee Pharmacy, Inc., Fort Smith, AR,

REASON Subpotent; betamethasone acetate.
VOLUME OF PRODUCT IN COMMERCE 722 vials.
DISTRIBUTION Nationwide.

WEEK ENDING APRIL 26

PRODUCT Glycopyrrolate USP, G136, bulk powder, drum, Rx only, Caution: For Manufacturing, Processing, or Repacking. .
CODE Lot# 021438.
RECALLING FIRM/MANUFACTURER Boehringer Ingelheim Chemicals, Inc, Petersburg, VA,

REASON Contamination; bulk drug contains glass.
VOLUME OF PRODUCT IN COMMERCE 28.7 kg.
DISTRIBUTION GA and Canada.

PRODUCT Zyvox oral suspension (linezolid for oral suspension), 100 mg/5 ml, 150 ml (when constituted), Rx only.
CODE Lots 11HKU, 97HAH, 82HHW, 16HXK, 61JBC, 94JAM, 08HDC, 10HHM, 22HFC, 63HJD, 64HJD, 11HMC, 12HMC, 34HMC, 75HKU, 86HMJ, 14JAH, 15JAH, 18HXP, 19HXP, 21HXP, 22HXP, 31JAK, 53JAY, 59JBC, 76HXP, 77HXK, 91HYT,and 96HWY.
RECALLING FIRM/MANUFACTURER Pharmacia Corporation, Kalamazoo, MI,

REASON Superpotent.
VOLUME OF PRODUCT IN COMMERCE 21,127 units.
DISTRIBUTION Nationwide and Austria, Australia, Barbados, Belgium, China, Equador, Germany, Greece, Hong Kong, India, Ireland, New Zealand, Qatar, Russia, Singapore, South Africa, Spain, Sri Lanka, Switzerland, and the United Kingdom

PRODUCT GEMZAR (Gemcitabine HCl For Injection),1 g equivalent to base, For I.V. use only, Sterile, Single Use Vial, Rx only , VIAL No. 7502.
CODE Lot# 5NG55M.
RECALLING FIRM/MANUFACTURER Lilly, Eli & Co., Indianapolis, IN,

REASON Lack of assurance of sterility (cracked vials).
VOLUME OF PRODUCT IN COMMERCE 112,210.
DISTRIBUTION Nationwide.

PRODUCT Norfloxacin USP, bulk powder, 25 g bottles, For Prescription Compounding, Caution: For Manufacturing, Processing or Repacking, Federal law prohibits dispensing without prescription.
CODE Lot 980611-3, Exp. 06/2003.
RECALLING FIRM/MANUFACTURER Medisca Pharmaceutique, Inc., Saint-Laurent, Canada,

REASON Mislabeled; bottle labeled to contain Norfloxacin USP actually contains Grepafloxacin USP.
VOLUME OF PRODUCT IN COMMERCE 2 - 25 gm units.
DISTRIBUTION Nationwide.