ENFORCEMENT REPORT FOR June 4, 2003

JUNE 2003

WEEK ENDING JUNE 7

PRODUCT Mytussin AC Cough Syrup, MGP, (Guaifenesin, USP 100 mg and Codeine Phosphate, USP 10 mg per (5mL) each teaspoon), Sugar-Free, NET: 4 fl oz (118mL), 1 Pint (473mL) and 1 Gallon (3785mL) bottles. Also sold under the following brand name in each container size - Robafen AC Cough Syrup.
CODE Lots 24071, 24195, 24337, 24421, 24423, 24492, 24535, 24541, 24591, 24650,24683, 24741, 24071A, 24071E.
RECALLING FIRM/MANUFACTURER Morton Grove Pharmaceuticals, Inc., Morton Grove, IL,
REASON Subpotent (codeine phosphate-18 month Stability test).
VOLUME OF PRODUCT IN COMMERCE 226,850 - 4 oz; 275,680 - 16 oz; 3,357 - 128 oz bottles.
DISTRIBUTION Nationwide.

PRODUCT Senokot Granules (standardized senna concentrate), Natural Vegetable Laxative, 15mg sennosides in each teaspoon, 6 oz and 12 oz bottles.
CODE Lot No. RR61 exp. 10/2007; RA02 exp. 10/2007; RA11 exp. 10/2007.
RECALLING FIRM/MANUFACTURER The Purdue Frederick Company, Stamford, CT,
REASON Mold contamination-Inactive ingredient-Malt syrup lot used in granule manufacturing had expired and was later found to contain surface mold.
VOLUME OF PRODUCT IN COMMERCE 4,296 - 6oz. bottles; 2,419 - 12 oz. bottles.
DISTRIBUTION Nationwide.

PRODUCT a) Premarin Tablets (conjugated estrogens tablets, USP), 0.625 mg, 100 tablet unit dose packages; 100 tablet bottles; and 5,000 tablet bottles. Rx only.
b) Premphase Tablets, 0.625 mg/5 mg (conjugated estrogens 0.625 mg and medroxyprogesterone acetate 5 mg tablets), Ez-dial dispenser
containing 28 tablets, Rx only.
CODE a) Lot #s: A09049 exp. April 2004 (100-tablet bottles); A09041 exp. April 2004 (5,000-tablet bottles); A09067 exp. April 2004 (100-tablet unit dose packages);
b) Lot #s: A09065 Exp. 11/03; A12270 Exp. 12/03; A09069, Exp. 12/03.
RECALLING FIRM/MANUFACTURER Robins Division of Wyeth, Richmond, VA,
REASON Dissolution failure; 18 month stability station-2 hour time point.
VOLUME OF PRODUCT IN COMMERCE 111,605 units.
DISTRIBUTION Nationwide.

***CORRECTION***

Premarin, stated Robins Division of Wyeth, Richmond, VA, as the recalling firm. The recalling firm name should be Richmond Division of Wyeth, Richmond, VA. The manufacturer is: Wyeth Pharmaceuticals, Inc., Rouses Point, NY.

Counterfeit Lipitor has turned up additional counterfeit quantities of the cholesterol-lowering pharmaceutical product. Two additional lots of 10 mg tablets in 90-tablet bottles, coded 20842V and 16092V, and one lot of 20 mg tablets in 90-tablet bottles, coded D270481, are involved. The labeling on each of these bottles states, “Repackaged by: MED-PRO, INC., Lexington, NE 68850.”

Healthcare providers and consumers should check the packaging very carefully before using Lipitor. Patients who have any of the product (labeled as “Repackaged by: MED-PRO, INC. Lexington, NE 68850”) with any of the following lot numbers should not take it, and they should return the product to their pharmacies:

20722V – 90-tablet bottles, 10 mg., Expiration 09-2004

04132V – 90-tablet bottles, 10 mg., Expiration 01-2004

16942V – 90-tablet bottles, 10 mg., Expiration 09-2004

20842V – 90-tablet bottles, 10 mg., Expiration 09-2004

16092V – 90-tablet bottles, 10 mg., Expiration 07-2004

D270481 – 90 tablet bottles, 20 mg.,Expiration not available.

Many patients taking Lipitor do not receive it in the 90-tablet bottles being recalled, but in smaller quantities from their pharmacists. Patients who are not sure whether they have the implicated product should check with their pharmacist.

WEEK ENDING JUNE 28

PRODUCT a) Methylene Blue Injection, USP, 1%, lmL, 10 vials per carton, Rx only.
b) Myochrysine, Gold Sodium Thiomalate Injection, USP, 50 mg/mL, 1 mL Single Dose Vials and 10 mL Multiple Dose Vials, Rx only.
c) Edex Diluent, (bacteriostatic 0.9% sodium chloride injection preserved with benzyl alcohol 0.945% w/v), 1.2mL syringe, Rx Only.
d) Sarapin Injection, 50 mL vials.
CODE
a) Lot 21192, Exp 2/04;
b) Lot 41092, Exp 4 (mL vial) Lots 41082, Exp 4/04 (10mL vial) and Lot 51242, Exp 5/04 (10mL vial);
c) Lots 61062, 121232;
d) Lots 31272, 41132, 51312.
RECALLING FIRM/MANUFACTURER Akorn, Inc., Decatur, IL.
REASON Lack of assurance of sterility.
VOLUME OF PRODUCT IN COMMERCE
a) 20,582 vials;
b) 19,168 vials;
c) not supplied;
d) 50,667 vials;
DISTRIBUTION Nationwide.

PRODUCT Cholestyramine for Oral Suspension, USP Powder, 4 grams cholestyramine resin, USP, per packet, 60 single dose packets, Apothecon.
CODE Lot no. 1A32512 Exp. Date 2/29/2004.
RECALLING FIRM/MANUFACTURER Recalling Firm: Bristol-Myers Squibb Company, New Brunswick, NJ.
Manufacturing Firm: Bristol-Myers Squibb Company, Prinston, NJ.
REASON Superpotent (6 month stability).
VOLUME OF PRODUCT IN COMMERCE 2,011 ctns/60 packets ea.
DISTRIBUTION Nationwide.

PRODUCT OxyContin Tablets (oxycodone hydrochloride controlled-release), 10 mg, 25 count unit dose packages, Rx only, For Hospital Use.
CODE Lot SG11 exp. 2/28/2006.

RECALLING FIRM/MANUFACTURER The Purdue Frederick Company, Stamford, CT.
REASON NDA Filing Discrepancy; supplement not filed for new supplier of inactive ingredient.
VOLUME OF PRODUCT IN COMMERCE 9,732-25 count blister packs.
DISTRIBUTION Nationwide.

Voluntary Recall of Viga or Viga for Women Tablets

Health Nutrition (RMA Labs) is warning its consumers not to purchase or consume the product known as VIGA or VIGA FOR WOMEN. These products which are being marketed as a dietary supplement contains the unlabeled drug ingredient sildenafil, which may pose possible serious health risks to some users. Viga is sold in bottles of 30 tablets, and in packet of 4 tablets (ten packets in one small box). VIGA for women is sold in bottle of 20 tablets. Both products are distributed by Health Nutrition (RMA Laboratories Inc) and sold without medical prescription.

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

Consumers who have purchased Viga or Viga for women tablets are urged to immediately discontinue their use and return them to their place of purchase or directly to Health Nutrition (RMA Laboratories), 6439 Alondra Blvd, Paramount, CA 90723. Consumers with questions regarding this recall may contact the company at 1-562-616-0100. Consumers who have purchased this product and have medical concerns should consult with their health care provider.