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December 26, 2000

Certain Lots of Premarin(r) Tablets Recalled

Orange, 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.

Recall #D-058-1.

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.

Selected Recent Recalls

Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.