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5/17/2002

Wyeth Recalls Premarin Tablets

Cheryl A. Thompson

Two lots of the conjugated estrogens product Premarin are being recalled because the tablets fall short of the pharmacopoeial requirement for dissolution, Wyeth Pharmaceuticals announced yesterday.

The company, in a letter dated May 16, asked customers to return the following Premarin 0.625-mg products: lot 9010509, packaged in bottles of 100 tablets; and lot 9010510, packaged in bottles of 5,000 tablets. Both lots have an expiration date of October 2003. This recall also applies to any repackaged products containing tablets from these lots.

Conjugated estrogens tablets, such as Premarin, must meet the specifications described in The United States Pharmacopeia for drug release from an extended-release article. Wyeth has recalled several lots of various Premarin tablet strengths in the past two years because of "dissolution failure."

Universal Rx Solutions, at 800-777-6565, is handling the logistics of the current recall.

In a separate communication, the company indicated that next week it will resume supplying Premarin 0.625-mg tablets in unit dose packages and 0.9-mg tablets in 100-count bottles. The 2.5-mg tablets in 100- and 1,000-count bottles remain out of stock, and the 1.25-mg tablets in unit dose packages will be available starting the week of June 10.