MARCH 2001

WEEK ENDING MARCH 2

PRODUCT: Pancrelipase Capsules.

CODE: Lot 40629 exp.12/00.

MANUFACTURER: Mutual Pharmaceutical Company, Inc., Philadelphia, PA.

DISTRIBUTION: Nationwide.

QUANTITY: 3,125 bottles.

REASON: Dissolution failure.

PRODUCT: Rx) Hydrocortisoneand Acetic Acid OTIC Solution, USP, 1%/2%, 10 mL bottle.

CODE: Lot No. 22864, exp. 05/01.

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

DISTRIBUTION: Nationwide.

QUANTITY: 66581 bottles.

REASON: Subpotency-Hydrocortisone (12th month of stability).

PRODUCT: a)(RX) Isosorbide Dinitate Tablets, 10 mg, bottles of 270 tablets. b)(RX) Tramadol HCL tablets, 50 mg, bottles of 240 tablets.

CODE: a) Lot No. 12040012, Exp. Date 12-28-01; b) Lot No. 112000TM94, Exp. 11-28-01.

MANUFACTURER: REGISTERED Repacker: Veteran’s Administration-Centralized Mail Order Pharmacy, Lancaster, TX.

DISTRIBUTION: S. Carolina, Virginia, and Kansas.

QUANTITY: a)3,700 bottles; b) 200.

REASON: Tablet mix-up. a) Furosemide 40 mg with isosorbide; Metoprolol b)Tartrate 50 mg with tramadol.

PRODUCT: Oxygen, USP, liquid, in Cryogenic Home Units.

CODE:

Lot # Serial #

120400-7 C065A86

120400-6 S021185

120400-7 C034K08

120400-6 S027185

MANUFACTURER: Kern Medical Inc. dba Dasco Home Medical Equipment Company, Alliance, OH.

DISTRIBUTION: Ohio.

QUANTITY: Four.

REASON: Use of improper oxygen analyzer for identity testing.

PRODUCT: (OTC) Medi-Tussin DM Cough Suppressant/Expectorant, (Dextromethorphan HBr, USP 10 mg/Guaifenesin, USP 100 mg), in 8 Fl. Oz. Bottles.

CODE:

9HD0020 mfr. Date 8/5/99, esp. 8/2002;

9GD0132 mfr. Date 7/15/99, exp. 7/2002;

0GD0326 mfr. Date 8/3/00, exp. 5/2003;

9GD0369 mfr. Date 8/1/99, exp. 7/2002;

9HD0021 mfr. Date 8/5,6/99, exp. 8/2002;

0GD0379 mfr. Date 8/1/00, exp. 5/2003.

MANUFACTURER: Perrigo, Allegan, MI.

DISTRIBUTION: Nationwide.

QUANTITY: 91,800 units.

REASON: Tussin DM product mislabeled as Tussin CF on the bottles.

PRODUCT: (Rx) Hydrocortisone and Acetic Acid OTIC Solution, USP, 1%/2%, 10 mL bottle.

CODE: Lot No. 22900, exp. 05/01; 22725, exp. 02/01; and 22761, exp. 02/01.

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

DISTRIBUTION: Nationwide.

QUANTITY: 66581 bottles.

REASON: Degradants; out of specification results during stability testing.

PRODUCT: (OTC) Adult low strength enteric coated aspirin tablets, 81 mg, 120 unit bottles.

CODE: 0032636; 0032637; 0032856; 0032858; 0033126; 0033127; 0033129; 0033203; 0033204; 0033459; 0043676; 0043691 and 0066784.

MANUFACTURER: Time-Cap, Inc., Farmington, NY.

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

DISTRIBUTION: MN; PA; NY; NC; MA; OH; CA; WA; CO; MD; AZ; OR; AR; FL.

QUANTITY: 109,716 bottles of 120 tablets each.

REASON: Superpotency.

WEEK ENDING MARCH 9

PRODUCT: Cydec Drops - Antihistamine/Decongestant, 1 fl. Oz. (30 mL) with dropper.

CODE: Lot nos. 02950 and 03110.

MANUFACTURER: Great Southern Laboratories, Houston, TX.

DISTRIBUTION: Nationwide.

QUANTITY: Lot 02950 - 6,135; Lot 03110 - unknown at this time.

REASON: Incorrect dosage instructions: Side panel labeling incorrectly declares measurement in "teaspoons" rather than correct "ML".

PRODUCT: (OTC) Anso Comfort(tm) Capsules, Extract of Hainanensis Merr Leaf, 200 mg, 60 capsules per bottle.

CODE: Lot 0H0041, Sept 2003 and Lot 9422, Exp 7-2002.

MANUFACTURER: Numeridian, Inc., Arcadia, CA.

DISTRIBUTION: AK, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, PA, RI, SC, TN, TX, UT, VA, WA, and WI. Foreign distribution was to China (Shanghai), and Canada (BC and Ontario).

QUANTITY: Lot OH0041, 6420 bottles; Lot 9422, unknown.

REASON: Product contains the undeclared prescription drug-chlordiazdepoxide.

WEEK ENDING MARCH 16

PRODUCT: Pharmacy’s Prescription, Fast-Acting Antacid Anti-gas, Original Flavor, 12 fl oz

CODE: Lot Number C-1188, Antacid Anti-Gas, Pharmacy’s Prescription Brand

MANUFACTURER: Aaron Industries, Inc., Lynwood, CA.

DISTRIBUTION: KY,CA, TN, NY.

QUANTITY: 10,498 units.

REASON: Microbial contamination-(Bacillus licheniformis).

PRODUCTS: a) Colgate Total Super Size 7.8 oz Toothpaste; b) Colgate Total Family size 6.0 oz Toothpaste; c) Colgate Great Regulator Flavor size 6.0 oz Toothpaste

CODES: a. SKU 74004, Exp. Date 03NOV02; b. SKU 74003, Exp. Date 03NOV02; c. SKU 72600, Exp. Date 03NOV02

MANUFACTURER: Colgate Palmolive, Jeffersonville, IN.

RECALLED BY: Colgate Palmolive, Piscataway, NJ

DISTRIBUTION: Nationwide.

QUANTITY:

a) Colgate Total Super size 7.8 oz -- 2813 cases

b) Colgate Total Family size 6.0 oz -- 2700 cases

c) Colgate Great Regular Flavor 6.0 oz -- 1862 cases

REASON: Microbial contamination- (Bacillus licheniformis).

WEEK ENDING MARCH 23

PRODUCT: (Rx) Trecator®-SC Sugar-Coated Tablets (Ethionamide), 250mg, 100 count.

CODE: LOT NO. 3990893, Exp. 11/04.

MANUFACTURER: Wyeth-Ayerst Laboratories, Rouses Point, NY.

RECALLED BY: Wyeth-Ayerst Laboratories, Richmond, VA

DISTRIBUTION: Nationwide and Sweden, New Zealand, and Czech Republic.

QUANTITY: 2,005 bottles.

REASON: Dissolution failure.

PRODUCT: (Rx) Leukeran® tablets (Chlorambucil), 2 mg, 50 count.

CODE: LOT NO. 0E2036.

MANUFACTURER: GlaxoSmithKline, Inc., Research Triangle Park, NC.

DISTRIBUTION: Nationwide and to GlaxoSmithKline Canada.

QUANTITY: 25,808 bottles, 7,200 (bulk) tablets were shipped to Canada.

REASON: Impurity specification failure (stability).

RAPLON Being Withdrawn From Market

The injectable anesthesia drug RAPLON (rapacuronium bromide) is being voluntarily withdrawn from the market after its manufacturer received reports indicating that the drug may be associated with bronchospasm - a mild to severe inability to breathe normally that can lead to permanent injury or death. Five deaths, reported to the manufacturer, occurred during the administration of Raplon.

The drug’s sponsor, Organon Inc., of West Orange, N.J., contacted FDA and sent a letter beginning March 27, 2001, to all anesthesiologists, hospital pharmacists, and other consignees of the drug, notifying them of the voluntary withdrawal of the drug and providing information on how to return unused inventory back to the company.