SEPTEMBER 2002

WEEK ENDING SEPTEMBER 7

PRODUCT Zerit (stavudine) Capsules, Capsule mixup; 20 mg or 30 mg capsule may be in bottles labeled as 40 mg capsules.
CODE Lot 1A36209, Exp. FEB 2003.
RECALLING FIRM/MANUFACTURER Recalling Firm: Alliance Wholesale Distributor, Richton Park, IL.
Manufacturer: Bristol-Myers Squibb Oncology/Immunology, Princeton, NJ.
REASON Tablets changed to capsules.
VOLUME OF PRODUCT IN COMMERCE 26 bottles.
DISTRIBUTION Nationwide.

PRODUCT Quinaglute (quinidine gluconate, USP), Dura-Tabs (extended-release tablets, USP) 324 mg, 100 count bottles, Rx only.

CODE Lot #012634, Exp. OCT 23 03; Lot #012831, Exp. NOV 27 03 ; Lot #012263, Exp. SEP 04 03.
RECALLING FIRM/MANUFACTURER Recalling Firm: AmeriSource Health Services Corp., Columbus, OH.
Manufacturer: Berlex Laboratories, Wayne, NJ.
REASON Metal particles found in tablet (by manufacturer).
VOLUME OF PRODUCT IN COMMERCE 687 bottles total.
DISTRIBUTION Nationwide.

PRODUCT Nasonex Nasal Spray (mometasone furoate monohydrate) 50 mcg, Net Contents: 17 g, 120 Metered Sprays, FOR INTRANASAL USE ONLY. Rx only.
CODE 1-KTL-147 Exp. date 3.03.
RECALLING FIRM/MANUFACTURER Recalling Firm: Schering Corpration, Kenilworth, NJ.
Manufacturer: Schering-Plough Products, Inc., Manati, Puerto Rico.
REASON Defective container; missing part in actuator may cause a narrow stream of product to be dispensed rather than a fine spray
VOLUME OF PRODUCT IN COMMERCE 295,620 units.
DISTRIBUTION Nationwide.

WEEK ENDING SEPTEMBER 21

PRODUCT Liquid Oxygen, USP, Medical, Cryogenic Home Units (models BP-21 and BP-41).
CODE Lot 08060239.
RECALLING FIRM/MANUFACTURER Recalling Firm: Health Care Solutions, Inc., Weirton, WV.
REASON Good Manufacturing Practice (GMP) deviations including, but not limited to, failure to test for purity and identity.
VOLUME OF PRODUCT IN COMMERCE 5 tanks.
DISTRIBUTION WV.

PRODUCT Desyrel Tablets (Trazodone HCL), 100 mg, 100 count bottles, Rx only.
CODE Lot # 0M03491, Exp. 11/02 Lot # 0M03491A, Exp. 11/02 Lot # 0E02305, Exp. 05/02.
RECALLING FIRM/MANUFACTURER Recalling Firm: AmeriSource Health Services Corp., Columbus, OH.
Manufacturer: Mead Johnson & Co., Evansville, IN.
REASON Lack of content uniformity-subpotent tablets (stability 18 month) by manufacturer-Mead Johnson Pharmaceuticals, A Bristol-Myers Squibb Co.
VOLUME OF PRODUCT IN COMMERCE 1,857 bottles.
DISTRIBUTION Nationwide.

PRODUCT Softsoap Antibacterial Liquid Hand Soap (with hand pump) Rainforest Series (triclosan), 7.5 FL OZ (221 mL) bottles.

CODE Rainforest product: SKU Number 127800 Code dates 2134,2135,2136 Rainforest product mixed product displays: SKU Number: 102781
Code Dates: 2158, 2161.
RECALLING FIRM/MANUFACTURER Colgate-Palmolive Co., Piscataway, NJ.
REASON Cross contamination with another soap product (contains undeclared ingredients: aloe vera, fragrance, glycerin, hydrolyzed silk).
VOLUME OF PRODUCT IN COMMERCE 19,293 cases.
DISTRIBUTION Nationwide.

PRODUCT Betamethasone Dipropionate Ointment USP (Augmented) 0.05%, 0.64 mg, 15g (0.53 oz) and 45g (1.59 oz) tubes, Rx only.

CODE a) Lot Number L105039; b) Lot Number L004054.
RECALLING FIRM/MANUFACTURER Alpharma Uspd, Inc., Lincolnton, NC.
REASON Subpotent.
VOLUME OF PRODUCT IN COMMERCE a) 8574 units; b) 5802 units.
DISTRIBUTION Nationwide.

WEEK ENDING SEPTEMBER 28

PRODUCT a) Tend Skin Lotion (acetylsalicylic acid) 9.7%, 4 oz. (118 mL), 8 oz. (236 mL) and 16 oz. (472 mL) bottles;

b) Soft Cell Topical Solution (acetylsalicylic acid) 4 oz bottles;

c) Bump No More Topical Solution (acetylsalicylic acid) 9.7%, 4 oz. (118 mL) and 16 oz. (472 mL) bottles;

d) Hard Top Intrinsic Nail Hardener Liquid (acetylsalicylic acid) 1/2 ounce;

e) PUREFECTION Topical Solid (acetylsalicylic acid) Net Wt 2.1 oz. bottle.

CODE All lot numbers are included in the recall.

RECALLING FIRM/MANUFACTURER Recalling Firm: Tend Skin International, Inc., dba The Tend Skin Company, Davie, FL

REASON Failure to comply with Over The Counter monographs (unapproved drug claims).

VOLUME OF PRODUCT IN COMMERCE 478,873.

DISTRIBUTION Nationwide.

PRODUCT a) Correctol Stimulant Laxative Tablet (Bisacodyl) Comfort-Coated, 5 mg, box of 10, 30, 60, 75 and 90;

b) Correctol Stimulant Laxative Caplet (Bisacodyl) Comfort-Coated, 5 mg, box of 30.

CODE

Description Lot Number

Expiration date

Correctol Tablets 5 mg (10 count) 0-LFK-81

07/31/02

Correctol Tablets 5 mg (10 count) 0-LFK-100

10/31/02

Correctol Tablets 5 mg (10 count) 0-LFK-103

10/31/02

Correctol Tablets 5 mg (10 count) 0-LFK-202

11/30/02

Correctol Tablets 5 mg (10 count) 0-LFK-204

11/30/02

Correctol Tablets 5 mg (10 count) 1-LFK-3

12/31/02

Correctol Tablets 5 mg (10 count) 1-LFK-33

05/31/03

Correctol Tablets 5 mg (30 count) 0-LFK-104

10/31/02

Correctol Tablets 5 mg (30 count) 1-LFK-9001

07/31/02

Correctol Tablets 5 mg (30 count) 1-LFK-9003

10/31/02

Correctol Tablets 5 mg (30 count) 1-LFK-9004

07/31/02

Correctol Tablets 5 mg (30 count) 1-LFK-9007

11/30/02

Correctol Tablets 5 mg (30 count) 1-LFK-9009

01/31/03

Correctol Tablets 5 mg (30 count) 1-LFK-9010

01/31/03

Correctol Tablets 5 mg (30 count) 1-LFK-9011

05/31/03

Correctol Tablets 5 mg (30 count) 1-LFK-9906

12/31/02

Correctol Tablets 5 mg (60 count) 0-LFK-96

10/31/02

Correctol Tablets 5 mg (60 count) 0-LFK-203

11/30/02

Correctol Tablets 5 mg (60 count) 1-LFK-9602

10/31/02

Correctol Tablets 5 mg (60 count + 15 bonus) 1-LFK-9601

10/31/02

Correctol Tablets 5 mg (60 count + 15 bonus) 1-LFK-9604

01/31/03

Correctol Tablets 5 mg (60 count) 1-LFK-12

12/31/02

Correctol Tablets 5 mg (60 count) 1-LFK-25

05/31/03

Correctol Tablets 5 mg (60 count) 1-LFK-28

05/31/03

Correctol Tablets 5 mg (60 count) 1-LFK-39

06/30/03

Correctol Tablets 5 mg (90 count) 1-LFK-9901

07/31/02

Correctol Tablets 5 mg (90 count) 1-LFK-9903

07/31/02

Correctol Tablets 5 mg (90 count) 1-LFK-9904

12/31/02

Correctol Tablets 5 mg (90 count) 1-LFK-9905

01/31/03

Correctol Tablets 5 mg (90 count) 1-LFK-9906

01/31/03

Correctol Tablets 5 mg (90 count) 1-LFK-9907

01/31/03

Correctol Tablets 5 mg (90 count) 1-LFK-9908

01/31/03

Correctol Tablets 5 mg (90 count) 1-LFK-1

11/30/02

Correctol Tablets 5 mg (90 count) 0-LFK-105

10/31/02

Correctol Caplets 5 mg (30 count) 0-CCT-101

10/31/03

RECALLING FIRM/MANUFACTURER Recalling Firm: Schering-Plough HealthCare Products, Cleveland, TN

Manufacturer: Schering Laboratories, Kenilworth, NJ.

REASON Disintegration; test data may not be supportive of expiration date.

VOLUME OF PRODUCT IN COMMERCE 5,312,274 packages.

DISTRIBUTION Nationwide.

PRODUCT Arm & Hammer PeroxiCare Baking Soda & Peroxide Tartar Control Toothpaste (Sodium Fluoride 0.24%) 4.3 oz, 6.0 oz and Special Pack tubes.

CODE 4.3 oz tubes --- UPC 33200-18750 Lot Numbers: L2043, L2051, L2057, L2058, L2063, L2064

6.0 oz tubes --- UPC 33200-18770 Lot Numbers: L2022, L2023, L2029, L2030, L2039, L2043, L2044, L2051, L2052, L2058, L2064, L2065, L2066,

L2073, L2074, L2112, L2113, L2121, L2135

Special Pack -- UPC 33200-18954 Lot Number: L2120

Mixed Display -- UPC 33200-18044 Eighteen PeroxiCare Tartar Control 6 oz in display of 66 mixed tubes of toothpaste Lot Numbers: L2010; L2079

Mixed Display -- UPC 33200-18045 Six PeroxiCare Tartar Control 6 oz in display of 69 mixed items of toothpaste, gum, and mints Lot Numbers: L2133

Mixed Display -- UPC 33200-18048 Twelve Peroxicare Tartar control 6 oz in display of 69 tubes. (not distributed; 100% still within Company

control).

RECALLING FIRM/MANUFACTURER Recalling Firm: Church & Dwight Co., Inc., Princeton, NJ.

REASON Labeling; product label does not declare inactive ingredient sodium saccharin.

VOLUME OF PRODUCT IN COMMERCE 40,774 cases (978,576 tubes).

DISTRIBUTION PA, OH, GA, CA and TX.

PRODUCT a) Correctol Stimulant Laxative Tablet (Bisacodyl) 5 mg, Comfort-Coated, box of 10, 30, 60, 75 and 90 Tablets;

b) Correctol Stimulant Laxative Caplet (Bisacodyl) 5 mg, Comfort-Coated, box of 30.

CODE

Item Code Description Lot Numbers

07299-17 Correctol Tablets 5 mg (90 count) 1LFK9902

07296-18 Correctol Tablets 5 mg (30 count) 1LFK9008

07300-17 Correctol Caplets 5 mg (30 count) 0CCT1, 0CCT2.

RECALLING FIRM/MANUFACTURER

Recalling Firm: Schering-Plough HealthCare Products Cleveland, TN

Manufacturer: Schering Laboratories, Kenilworth, NJ.

REASON Disintegration; failures at the one hour test time (stability).

VOLUME OF PRODUCT IN COMMERCE 5,312,274 packages.

DISTRIBUTION Nationwide.