March 29, 2002Wyeth-Ayerst Has Recalled Premarin
Richmond, VA (SafetyAlerts)
- The Food and Drug Administration (FDA) said that Wyeth-Ayerst Laboratories has recalled
Premarin Tablets (conjugated estrogens tablets, USP) 0.625 mg,
Rx Only, Ayerst Laboratories, Inc., Philadelphia, PA. Recall # D-216-2.
Bottles of 100 - NDC #0046-0867-81
Bottles of 1000 - NDC #0046-0867-91
Bottles of 5000 - NDC #0046-0867-95.
9001566, exp. 07/03
9010254, exp. 07/03
9010255, exp. 07/03.
Recalling Firm: Wyeth-Ayerst Laboratories, Richmond, VA, by letters dated
February 21, 2002.
Manufacturer: Ayerst Laboratories, Inc., Rouses Point, NY.
Firm initiated recall is ongoing.
Failure to meet dissolution specifications.
VOLUME OF PRODUCT IN COMMERCE
47,024 btls of 100; 9,255 btls of 1000; and 1,408 btls of 5000.