APRIL 2001

WEEK ENDING APRIL 6

PRODUCT: (OTC) Aldroxicon II Double Strength antacid/anti-gas liquid, (Aluminum Hydroxide 400 mg, Magnesium Hydroxide 400 mg,

Simethicone 40 mg), 30 mL screw cap tubes in units of 10 per box.

CODE: Lot #10056.

MANUFACTURER: York Pharmaceuticals, Kansas City, KS.

RECALLED BY: Textilease Medlique, Wood Dale, IL & unit dose packager, Specialty Packaging, Somerville, NJ

DISTRIBUTION: In Arizona, Texas, Illinois, Georgia, Louisiana, Ohio, Connecticut, Alabama, Wisconsin, and North Dakota.

QUANTITY: 33 cartons of 10 tube each and 227 cartons of 50 tubes.

REASON: The product exceeded the microbial limits for release.

PRODUCT: Vercuronium Bromide Injection, 10 mg, 1 mg/ml.

CODE:

Lot 99M090 Schein Pharmaceutical

Lot 99M130 Schein Pharmaceutical

Lot 99N140 American Pharmaceutical Partners

MANUFACTURER: Steris Laboratories, Inc., Phoenix, AZ.

DISTRIBUTION: AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, ME, MN, MO, MS, NC, ND, NJ, NM, NY, OH, OR, PA, SC, TN, TX,

UT, WA, WI, WV, Puerto Rico and Canada.

QUANTITY: 36510 lot 99M090, 48150 lot 99M130, 47110 lot 99N140

REASON: Lack of Assurance of Sterility-filter validation.

PRODUCT: Liqui-Doss® liquid for constipation (Mineral Oil 13.5mL/15mL), 2 and 16 Fl. Oz. Bottles

CODE: LOT NOS. 57-142, 57-144, 57-145, 57-152, 58-055, 58-057, 58-058, and 58-063.

MANUFACTURER: Ferndale Laboratories, Inc., Ferndale, MI.

DISTRIBUTION: United States.

QUANTITY: 28,564 bottles.

REASON: Possible yeast contamination

PRODUCT: (Rx) Hydromorphone HCL Injection, USP, 4 mg/20mL (0.2 mg/mL), 20 mL vial.

CODE: LOT NOS. SV000E0 and SV001E0, and SV002E0.

MANUFACTURER: THE International Medication Systems LTD., South EL Monte, CA.

DISTRIBUTION: AL, CO, GA, KY, MI, MS, NY, TN, WA, AZ, CT, IL, LA, MN, NC, OH, TX, WI, CA, FL, IN, MA, MO, NJ, PA, VA

QUANTITY: 23,990 units.

REASON: Stability; Failure to meet potency specification prior to Labeled expiry (Subpotency).

PRODUCT: (OTC) Maximum Strength Sinus Tablets (Acetaminophen 500 mg, Pseudoephedrine HCL 30mg, Chlorpheniramine Maleate 2 mg 24 counts.

CODE: Lot RM0260 (Bulk Lot Numbers 9046800, 9046801, 9046545, 9046546, 9068812, 9070507, 9070505, 9082222, 9082226, 9082225, 9093966, 9105984, 9105986, 0022054).

MANUFACTURER: Contract Pharmacal Corp., Hauppauge, NY.

RECALLED BY: Leiner Health Products, Inc., Carson, CA

DISTRIBUTION: AR and OH.

QUANTITY: 883,493 units packaged with 798,580 units distributed.

REASON: Subpotency and dissolution failures at 12 months of expiry.

PRODUCT: (Rx) Methyldopa Tablets, USP, 250 mg, 100 count bottles.

CODE: LOT NO. 465-916, Exp. Date 6/02, Batch #1404.

MANUFACTURER: Wyeth-Ayerst/Lederle, Pearl River, New York.

RECALLED BY: ESI Lederle, Philadelphia, PA

DISTRIBUTION: AL, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MA, MD, MI, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC,

TN, TX, UT, VA, VT, WA, WI, WV and Puerto Rico.

QUANTITY: 14,402 bottles of 100.

REASON: Tablet Discoloration.

PRODUCT: Prax ® Lotion, (Pramoxine HCL 1%), 15 mL, physician samples

CODE: LOT NOS. 57-209A, 58-007, 58-203.

MANUFACTURER: Ferndale Laboratories, Inc., Ferndale, MI.

DISTRIBUTION: United States.

QUANTITY: Not provided.

REASON: Subpotency (at 12 month stability).

Aventis Pharmaceuticals is initiating a voluntary recall of Taxotere® (docetaxel) for Injection Concentrate 20-mg active and diluent vials. The lot numbers for this recall are: 0P273 (active) which was packaged together with diluent vials with the following lot numbers 0T446 (diluent) or 0T449 (diluent). TAXOTERE® (docetaxel) for Injection Concentrate 20-mg. It has been determined that the Taxotere 20mg vial containing the active ingredient may have inadvertently been labeled as a "diluent" vial. Aventis has received one product complaint related to this mislabeling. Customer Service Department at 1-800-207-8049. For Medical Information questions or to report an Adverse Event please call, 1-800-633-1610. www.aventispharma-us.com

WEEK ENDING APRIL 13

PRODUCT: Midazolam HCl Injection, 1 mg/ ml and 5 mg/ml; the product was filled in 3.5 ml vials, 10 vials per carton, in the following strengths and sizes:

a) 1 mg/ml - 2 ml fill vial

b) 5 mg/ml - 1 ml fill vial; 2 ml fill vial

CODE:

a) 1 mg/ml: 2 ml vials, lots 0C590, 0C630, 0C640, 0C960, 0C970, 0D670, 0D750

b) 5 mg/ml: 1 ml vials, lots 0C810, 0C820, 0C910; 2 ml vials, lots 0C900, 0C980

MANUFACTURER: Novex Pharma, Ontario, Canad.

RECALLED BY: Aptoex Corp., Vernon Hills, IL

DISTRIBUTION: California, Michigan, Washington, Hawaii and Oregon.

QUANTITY: 64320 2 ml vials-1 mg., 3110 1 ml vials & 3890 2 ml vials-5mg.

REASON: Lack of assurance of sterility - cracks in some vials.

PRODUCT: (Rx) Isoxsuprine HCI tablets, 20 mg, 1,000 count.

CODES: Lot Nos. 00504, 00602, and 00603.

MANUFACTURER: Integrity Pharmaceutical Corp., Fishers, Indiana.

DISTRIBUTION: United States.

QUANTITY: 11,818 bottles.

REASON: Metal particles in tablets.

PRODUCT: Taxotere (docetaxel) for Injection Concentrate 20-mg., 20-mg. docetaxel in 0.5 ml polysorbate 80, 10 mg/ml after the initial dilution, RX, for IV infusion only, indicated for the treatment of breast cancer and non-small cell lung cancer, NDC #0075-8001-20, NDA #20-449. The product consists of two vials. One vial contains the Taxotere and has a green flip-top cap, and the other vial contains Diluent for Taxotere 20 mg., containing 13% (w/w) ethanol in water for injection, and has a clear flip-top cap. The two vials are packaged together in a labeled tray. The tray is contained within a labeled box.

CODES: Lot #OP273 (Taxotere), OT446 (Diluent), Exp. 4/2002; Lot #OP273 (Taxotere), OT449 (Diluent), Exp. 4/2002.

MANUFACTURER: Aventis Pharma, Ltd., England, UK.

RECALLED BY: Aventis Pharmaceuticals, Inc., Kansas City, MO

DISTRIBUTION: AL, IL, TN, NC, MN, FL, OH, KY, MA, NJ, OR, CA, SC, and MI.

QUANTITY: 28,774/2-vial units

REASON: Mislabeling; Both the active ingredient vial and the diluent vial are labeled as DILUENTS.

PRODUCT: OTC) Acetaminophen Caplets, Extra Strength, 500 mg, 24,50,100, 120, 175, and 500 count.

CODES: Lot Number 1281 (Bulk Lot Numbers W9071027R, W9071028R, W9081167R, W9081168R, W9091370R, W9101447R, W0020276R)

Lot Numbers: 0010027, 0019523, 0044473, 0044390, 0044393, 0044641, 0044642, 0044643, 0044644, 0054814, 0055201, 0055202, 0055203, 0055204, 0055959, 0055960, 0067254, 0067255, 9082276, 9082277, 9082278, 9082280, 9082281, 9082282, 9082284, 9082285, 9082320, 9082321, 9082322,

9082323, 9093579, 9093579, 9094484, 9094485, 9094486, 9094487, 9094488, 9094490, 9094491, 9094492, 9094493, 9094494, 9094582, 9094583, 9094586, 9094588, 9094591, 9094592, 9094593, 9094705, 9105451, 9105857, 9106368, 9106369, 9106370, 9106371, 9106372, 9106375, 9106380,

9106385, 9106388, 9106391, 9106395, 9116914, 9117201, 9117217, 9117218, 9117223, 9117225, 9117227, 9117228, 9117230, 9117365, 9128851.

MANUFACTURER: Leiner Health Products, Inc., Wilson, NC .

RECALLED BY: Leiner Health Products, Inc., Carson, CA

DISTRIBUTION: AR, CT, FL, IN, MA, MN, NJ, NY, NC, OH, PA, TN.

QUANTITY: 376,801 units were packaged and 362,953 units were distributed.

REASON: MIS-LABELING; Labeling incorrectly declared an extended expiration date.

PRODUCT: a) MGP Multi-Vita Drops with Fluoride 0.25 mg., product code 8659

b) MGP Multi-Vita Drops with Fluoride 0.5 mg., product code 8496

CODES: Product Code 8659, lots 22647A, 22431A, 22657A, 22534A, 22534C, 22534E, 22884-A, 22998A, 23077A, 23184A, 23232A, 23351A;

Product code 8496, lots 22308A, 22460A, 22602A, 22602C, 22769A, 23000A, 23000C, 23032A.

MANUFACTURER: Morton GrovePharmaceuticals, Inc., Morton Grove, IL.

DISTRIBUTION: Nationwide.

QUANTITY: 434378 – 0.25 mg. Fluoride bottles, 53323 – 0.5 mg. Fluoride bottles.

REASON: Subpotency prior to expiration date; vitamin C (ascorbic acid.)

PRODUCT: (Rx)Fluocinolone Acetonide Solution, USP, 0.01%, 20 and 60 mL units.

CODE: LOT NO. N133, Exp. Date 12/01.

MANUFACTURER: Thames Pharmacal Co., Inc., Ronkonkoma, NY.

DISTRIBUTION: KY, FL, GA, NY, IL, MI, LA, AL, MO, WI, CA, TX, PA, MN, OH, and Puerto Rico.

QUANTITY: 7,007 units of the 20 mL bottles and 3,450 units of the 60 mL bottles.

REASON: Subpotency (12th month stability).

PRODUCT: Garamycin Ophthalmic Olution Gentamicin Sulfate Ophthalmic Solution, USP)3 GM/ML, 5 ML Bottles, NDC 0085-0899-05

Gentak Sterile Solution, DC 17478-283-0,PRIVATE LABEL for AKORN, INC., Buffalo Grove, Illinois.

CODE:

LOT NO. EXP. DATE

0-AMS-2 10/2003

9-AMS-2 3/2002

9-AMS-3 6/2002

9-AMS-4 12/2002

8-AMS-5 5/2002

8-AMS-7 8/2001

8-AMS-9 8/2001

8-AMS-12 12/2001

GENTAK LABEL

9-AMS-1 2/2002

8-AMS-3 2/2001

8-AMS-4 5/2001

8-AMS-5 5/2001

8-AMS-8 8/2001

8-AMS-10 11/2001

8-AMS-11 11/2001

MANUFACTURER: SCHERING Labortories, Kenilworth, NJ.

DISTRIBUTION: Nationwide.

QUANTITY: Approximately 389,089 units.

REASON: Chemical Contamination-Dicyclohexyl Phthalate (DCHP) Product Label adhesive migration.

PRODUCT: Inderide LA 160 mg/50 mg caps (Propranolol HCL 160 mg/Hydrochlorothiazdie 50 mg), NDC 0046-0459-81, bottles of 100 caps. 24 bottles of 100's per shipper.

CODE: Lot no. 999041 exp. date 7/01.

MANUFACTURER: Wyeth Pharmaceuticals Company, Guayama, PR.

DISTRIBUTION: Nationwide.

QUANTITY: 5, 576 bottles of 100.

REASON: Dissolution failure for Hydrochlorothiazide component.

PRODUCT: True Care Decongestant Nasal Spray, 1/2 fl. oz., Ozymetazoline Hydrochoride 0.05%, NDC 57394-608-06.

CODE: Lot N416

MANUFACTURER: Thames Pharmaceutical Co. inc., Ronkonkoma, NY./

RECALLED BY: Apothecary Products, INC

DISTRIBUTION: Kansas City, MO.

QUANTITY: About 920 mislabeled bottles.

REASON: Mislabeling; Failure to declare warning against use if heart disease exists.

PRODUCT: Geneva Pharmaceuticals Amoxycillin 250 mg capsules. Amoxycillin 500 mg capsules.

NDC #00781-2020-01 (250 mg 100's);

NDC #00781-2020-05 (250 mg 500's);

NDC #00781-2613-01 (500 mg 100's);

NDC #00781-2613-05 (500 mg 500's).

CODES:

Lot Numbers and exp dates:

107283 05/02

107284 05/02

107285 05/02

107297 06/02

108375 09/02

108376 09/02

108377 09/02

108378 09/02

108379 09/02

108865 11/02

108866 11/02

108867 11/02

108868 10/02

109430 11/02.

MANUFACTURER: Biochemie GmbH, Tyrol, Austria.

RECALLED BY: GENEVA Pharmaceuticals, Broomfield, CO

DISTRIBUTION: CO, FL, NY, OK, VA.

QUANTITY: 7,495,900/ 250mg capsules, 14,859,600/ 500mg capsules.

REASON: Unapproved Drug: Drug distributed prior to approval of manufacturing changes.

PRODUCT: a) (?) Premarin® tablets (conjugated estrogens tablets), 0.625 mg, 100 & 1,000 count bottles.

b)(?) Premarin® tablets (conjugated estrogens tablets), 2.5mg, 100 count bottles

CODES:

Strength Bottle Size NDC # Leiner Lot # Wyeth-Ayerst Lot #

a) 0.625mg 100 count 0046-0867-81 8K01061 9980299

0.625mg 100 count 0046-0867-81 8H03878 9980299

0.625mg 100 count 0046-0867-81 9D00864 9990298

0.625mg 1000 count 0046-0867-91 9D00862 9990298

0.625mg 1000 count 0046-0867-91 8H02890 9980299

b) 2.5mg 100 count 0046-0865-81 9F01554 9990283

MANUFACTURER: Ayerst Laboratories Inc. A Wyeth-Ayerst Company, Philadelphia, PA

DISTRIBUTION: NY, CA, IL.

QUANTITY:

Strength Bottle Size Wyeth-Ayerst Lot # Leiner Lot # #of Bottles Produced

0.625mg 100 count 9980299 8K01061 & 8H03878 5916

0.625mg 100 count 9990298 9D00864 & 9D00862 27,069

0.625mg 1000 count 9980299 8H02890 1800

2.5mg 100 count 9990283 9F01554 4200

REASON: Dissolution failure by manufacturer (AYERST LABORATORIES).

WEEK ENDING APRIL 20

PRODUCT: (Rx) Colchicine Injection, 0.5 mg, 30 ml Multiple Dose Vial.

CODE: Lot No. 1EC093000.

MANUFACTURER: Amram Inc., Rathdrum, Idaho.

RECALLED BY: Phyne Pharmaceuticals, Inc., Scottsdale, AZ

DISTRIBUTION: Nationwide to physicians.

QUANTITY: 33 vials.

REASON: Super-Potency (By Mis-Formulation).

WEEK ENDING APRIL 27

PRODUCT: (Rx) Methocarbamol,USP, bulk active pharmaceutical ingredient, 25 kilo drums

CODE: Lot Nos. 79081-79188 and 89001-89032 (140 lots).

MANUFACTURER: Tianjin Xin Xin Pharmaceutical Corp., Tianjin, China.

RECALLED BY: THE Aceto Corporation, Lake Success, New York

DISTRIBUTION: New York, Ohio, and Colorado.

QUANTITY: 140 lots.

REASON: Metal particles in bulk active drug substance.