JUNE
2001
PRODUCT: a) Diflucan (Fluconazole) injection 400 mg (200 mL Saline Bags)
b)
Diflucan (Fluconazole) injection 400 mg
(200 mL Dextrose Bags).
CODE: a) Lot no. PS102145, Exp. 10/02, 200 mL Saline Bags;
Lot PS103606, Exp. 11/02, 200 mL Saline Bags.
b)
Lot PS102327, Exp. 10/02, 200 mL Dextrose Bags; Lot PS103507, Exp. 11/02, 200
mL Dextrose Bags.
MANUFACTURER: Baxter HealthCare Corp. Jayuya, PR.
RECALLED BY: Pfizer, Inc, New York, NY
DISTRIBUTION: Nationwide.
QUANTITY: 15,251 units.
REASON: Lack of assurance of sterility.
PRODUCT: Eagle brand Medicated Oil, 0.8 fl. Oz. (24ml) glass bottles
CODES: All lot codes.
MANUFACTURER: Wilhelm Hauffman and Corporation, Singapore
DISTRIBUTION: CA,CO,FL,GA,IL,KS,MA,MI,MN,NY,PA,TX,WA, and
D.C.
QUANTITY: 288,000 bottles of 0,8 fl.oz.each.
REASON: Superpotency: methyl salicylate.
PRODUCT: Perphenazine Tablets, USP (Gray) a) 2 mg. tablets; b) 4 mg. tablets;
c) 8 mg. tablets; d) 16 mg. tablets
Packaged
in unit dose blisters 10 unit dose tablets per card, 10 cards per shelf carton.
CODE: a) lots 0B224, 0J900, 1A680; b) lots 0C382, 0J891,
0S474, 1B909; c) lots 0A067, 0P287; d) lots 0B119, 0S399.
MANUFACTURER: Zenith Goldline Pharmaceuticals, Northvale,
NJ.
RECALLED BY: UDL Laboratories, Inc., Rockford, IL
DISTRIBUTION: Nationwide.
QUANTITY: a) 3939; b) 3894; c) 3541; d) 1183.
REASON: Discoloration of tablets prior to expiry.
WEEK ENDING JUNE 16
PRODUCT: Serostim® 6 mg [Somatropin (rDNA origin) for
injection], Rx. Each box contains 7 vials of Serostim® and 7 vials of sterile
water for injection (diluent). Product is used for the treatment of AIDS
patients.
CODE: Lot MNK612A (exp. “08/02”)
RECALLING FIRM/DISTRIBUTOR: Bellco Drug Corp.,
Amityville, New York.
RESPONSIBLE FIRM AND MANUFACTURER: Unknown.
RECALLED BY: Bellco Drug Corp.
DISTRIBUTION: NY.
QUANTITY: Unknown.
REASON: Counterfeit.
PRODUCT: Serostim® 6 mg [Somatropin (rDNA origin) for
injection], Rx. Each box contains 7 vials of Serostim® and 7 vials of sterile
water for injection (diluent); used for the Treatment of AIDS patients.
CODE: Lot MNK612A (exp.
“08/02”).
RESPONSIBLE FIRM AND MANUFACTURER: Unknown.
RECALLED BY: Quality King Distributors,
Inc., Ronkonkoma, New York
DISTRIBUTION: Nationwide.
QUANTITY: Lot MNK612A (exp. 08/02) -
250 boxes.
REASON: Counterfeit.
PRODUCT: Serostim 6 mg, (somatropin (rDNA origin) for
injection, each carton contains seven vials of containing 6mg of somatropin,
and seven vials of sterile diluent each containing 1 mL.
CODE: MNK612A EXP 08/02, NDC
44087-0006-7.
DISTRIBUTOR: Professional Wholesale,
Inc., Baldwin Park, CA.
RESPONSIBLE FIRM AND MANUFACTURER: Unknown.
DISTRIBUTION: AR, CA, KY, and TX.
QUANTITY: 507 cartons.
REASON: Counterfeit.
PRODUCT: Serostim 6 mg, (somatropin (rDNA origin) for
injection, each carton contains seven vials of containing 6mg of somatropin,
and seven vials of sterile diluent each containing 1 mL.
CODE: MNK612A. Exp "08/02".
RESPONSIBLE FIRM AND MANUFACTURER: Unknown.
RECALLED BY: Dutchess Business
Services, Inc., Las Vegas, NV
DISTRIBUTION: KY, NV, NY, and CA.
QUANTITY: 807 boxes.
REASON: Counterfeit.
WEEK
ENDING JUNE 23
PRODUCT: Oxygen, USP, Liquid, 196
Liter Dewars (Tanks).
CODE:
Lot #: Exp.
Date
333F001 28NOV2001
333F002 28NOV2001
333F003 28NOV2001
334F001 29NOV2001
334F002 29NOV2001
334F003 29NOV2001
340H001 05DEC2001
340H002 05DEC2001
340H002 05DEC2001
341F001 06DEC2001
341F002 06DEC2001
341F003 06DEC2001
MANUFACTURER: BOC Gases, Dayton,
OH.
RECALLED
BY:
BOC Gases, Murray Hill, NJ
DISTRIBUTION: OH.
QUANTITY: 12 cylinders.
REASON: MISBRANDED; Liquid Oxygen
DEWAR (TWO LABELS-OXYGEN/NITROGEN) with non-permanent fittings involved in
deaths.
PRODUCT: Serostim vial, 6 mg,
(somatropin (rDNA origin) for injection, NDC 44087-0006-07, Cartons of 7 units
CODES: Lot No. MNK612A, Exp
08/02.
RESPONSIBLE
FIRM AND MANUFACTURER: Unknown.
RECALLED
BY: C
& H Wholesale, Inc., Davie, FL
DISTRIBUTION: NJ and FL.
QUANTITY: 36 boxes.
REASON: Counterfeit.
PRODUCT: Serostim Vial, 6 mg,
(somatropin (rDNA origin) for injection), NDC 44087-0006-07, cartons of 7
CODES: Lot No: MNK612A.
RESPONSIBLE
FIRM AND MANUFACTURER: Unknown.
RECALLED
BY:
BERGEN BRUNSWIG DRUG CO., Orange, CA
DISTRIBUTION: CA, HI, TX, WA, MD, BUT
MOSTLY CA.
QUANTITY: 9,998 VIALS.
REASON: Counterfeit.
PRODUCT: (Rx) Hydrocortisone and
Acetic Acid OTIC Solution, USP, 1%/2%, 10 mL bottle.
CODES: LOT NO. 22900, 22725, and
22761. Recall Extended to include lots: 22835A, 22997A, 23026A, 23060A, 23097A,
23160A, 23160C, 23246A, 23287A, 23343A, 23419A, 23419C, 23466A, 23474A, 23474C,
23496A, 23497A, 23497C, 23570A, 23601A, 23627A, 23667A, 23667C
MANUFACTURER: Morton Grove
Pharmaceuticals, Inc., Morton Grove, IL.
DISTRIBUTION: Nationwide.
QUANTITY: 328,022 units.
REASON: DEGRADANTS; OUT OF
SPECIFICATION RESULTS DURING STABILITY TESTING.
PRODUCT: LotriminĆ AF Spray Liquid,
4 oz. (113 gram) Aerosol can, The product is an OTC, topically applied
antifungal aerosol. The active ingredient is 2% Miconazole Nitrate
CODES: Lot Number 1A05CC.
1A05CCC Exp 01 04.
MANUFACTURER: CCL Custom Manufacturing,
Inc. Cumberland, RI.
RECALLED
BY:
Schering-Plough HealthCare Products, Cleveland, TN
DISTRIBUTION: Nationwide.
QUANTITY: 96,500 units (individual
cans).
REASON: MISBRANDING ; Lotrimin AF
Liquid Spray was incorrectly labeled as Lotrimin AF Deodorant Powder.
PRODUCT: Z-52 Nighttime Sleep Aid
(Diphenhydramine HCI) 50 mg. Tablets.
The product is sold in 50 count bottles; one case contained 144 bottles.
CODES: Lot 6072 exp.JAN 02.
MANUFACTURER: Nittany Pharmaceuticals,
Inc., Milroy PA.
DISTRIBUTION: IN.
QUANTITY: 144 bottles.
REASON: Misbranded; product is
labeled with an expiration date having no supporting stability data.
PRODUCT: Scot-Tussin Original Clear
Five-Action Cold and Allergy Formula SUGAR FREE, 4 FL.OZ. AND 16 FL. OZ
bottles.
CODES: Lot Number: 201027. Exp. 10-2002.
MANUFACTURER: Scot-Tussin Pharmacal Co.,
INC., Cranston, RI.
DISTRIBUTION: Nationwide.
QUANTITY: 4 fl. oz =576 units 16 Fl.
oz.=2735.
REASON: STABILITY FAILURE FOR
SODIUM SALICYLATE COMPONENT.
PRODUCT: a) SCOT-TUSSIN ALLERGY
Relief Formula Clear SUGAR FREE [OTC Antihistamine] packaged in 4 Fl Oz Bottles
b) SCOT-TUSSIN SENIOR Clear
Sugar Free [OTC Expectorant, Cough Suppressant] Packaged in 4 Fl. OZ.
bottles.
CODES: a) Lot Numbers: 980102
and 990121. Exp. Date: 1/2003; b) Lot
Number: 970113. Exp. Date:
01/2002.
MANUFACTURER: SCOT-TUSSIN PHARMACAL CO.,
INC. Cranston, RI.
DISTRIBUTION: Nationwide.
QUANTITY: a) Allergy: 4 oz. =4918
units; b) Senior: 4 oz.=10,166.
REASON: a) Allergy Relief tested
subpotent for Diphenhydramine. b) Senior tested superpotent for guaifenesin.
PRODUCT: Enteric Coated Aspirin
Tablets, 325 mg. under the Pharmacist Formula and Hannaford labels in 100
tablet bottles.
CODES: Lot 0A01453.
MANUFACTURER: LNK International
Hauppauge, NY.
RECALLED
BY:
Leiner Health Products, Inc., Carson, CA
DISTRIBUTION: FL, IL, MD, ME, VT, VA.
QUANTITY: 18,888 bottles.
REASON: DISSOLUTION FAILURE (18
MONTH STABILITY).
PRODUCT: Pharmacist FormulaĆ
Maximum Strength Non-Aspirin Sinus Caplets, (Acetaminophen 500mg/Pseudophedrine
HCL 30mg), units of 24.
CODES: LOT NO. OPB1174.
MANUFACTURER: Leiner Health Products,
Inc., Carson, CA.
DISTRIBUTION: OH.
QUANTITY: 6,432.
REASON: MISBRANDING: BLISTER
STRIPS INCORRECTLY LIST CHLORPHENIRAMINE MALEATE AS AN INGREDIENT.
PRODUCT: Indapamide Tablets, USP
2.5 mg, NDC 0172-4259-60 (100 count) and NDC 0172-4259-80 (1000 count) package
in bottles of 100 and 1000 tablets. ANDA 74-299. Rx product.
CODES: Lot no. 4259-710.
Exp. Date 10/02.
MANUFACTURER: Zenith Laboratories
Caribe, Inc., Cidra, PR.
DISTRIBUTION: Nationwide.
QUANTITY: 12,334 bottles (100 count)
and 1,602 (1000 count).
REASON: Illegible monograph on
tablets.
WEEK ENDING JUNE 30
PRODUCT: Oxygen, USP Compressed, size B, D and E aluminum and steel cylinders
CODES: Lots 116T102 and 116T103.
MANUFACTURER: Valley National Gases, INC., Charleston,
WV.
RECALLED BY: Valley National Gases, INC., Wheeling, WV
DISTRIBUTION: WV.
QUANTITY: 178 cylinders.
REASON: Oxygen cylinders were sold unfilled/empty.