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Premarin shortage possible

Executive Summary

Supply shortages of Premarin (conjugated estrogens) may occur in one or more dosage strengths, American Home Products said in its Aug. 14 10-Q filing. On Aug. 8, Wyeth-Ayerst recalled two lots totaling more than 10 mil. tablets of the 1.25 mg strength. The recall is the sixth for dissolution failure since October (1"The Pink Sheet" Dec. 11, 2000, In Brief). Wyeth and FDA are discussing problems associated with failure to meet dissolution standards

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Class III recall of 51 lots of conjugated estrogen tablets is not related to an inspection or warning letter, Wyeth-Ayerst says. The Premarin and Premphase products involved in the Oct. 16 recall were manufactured at Wyeth's Rouses Point, N.Y. and Guayma, Puerto Rico plants. Wyeth's Pearl River, N.Y. and Marietta, Penn. injectable manufacturing plants are currently operating under an FDA consent decree. (For more information on the recall, see FDA's Dec. 6 "Enforcement Report," p. 26.)

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