December 26, 2000Certain Lots of Premarin(r)
CA (SafetyAlerts) - The Food and
Drug Administration (FDA) said today that Bergen Brunswig Corporation is recalling certain
lots of Premarin(r) Tablets because of dissolution failure by manufacturer (Wyeth Ayerst).
This is the first public notice of
this Class III
recall issued by FDA.
Premarin(r) Tablets, 2.5 mg (Conjugated Estrogen Tablets, USP), in 100-count
bottles. NDC #0046-0865-81.
Lot Numbers: R9K00522 EXP 08/01, R9K00522A EXP 08/01, R9K00608 EXP 09/01, R9K00608A 09/01.
Ayerst Laboratories, Division of Wyeth-Ayerst Pharmaceuticals, Inc., Rouses Point, New
York; and Wyeth Pharmaceuticals, Company, Guayama, Puerto Rico.
Bergen Brunswig Corporation, Orange, California, by letter dated November 2, 2000.
Firm-initiated recall ongoing.
Nationwide and Puerto Rico.
5,086 100-tablet bottles were distributed.
Questions concerning this recall may be directed
to the FDA at 1-888-INFO-FDA.
Notice of this product warning was sent via email
to SafetyAlerts subscribers December
26, 2000. For more information regarding the SafetyAlerts free email alert service
please click here.
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