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SafetyAlerts
April 12, 2001

Premarin® Tablets Recalled

Philadelphia, PA (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Ayerst Laboratories Inc. has recalled Premarin® tablets because of dissolution failure by manufacturer.

This is the first public notice of this Class III recall issued by FDA.

PRODUCT
a) (?) Premarin® tablets (conjugated estrogens tablets),
0.625 mg, 100 & 1,000 count bottles. Recall #D-168-1;

b)(?) Premarin® tablets (conjugated estrogens tablets), 2.5mg, 100 count bottles Recall #D-169-1.

CODES:
Strength, Bottle Size, NDC #, Leiner Lot #, Wyeth-Ayerst Lot #.
a)

0.625mg, 100 count, 0046-0867-81, 8K01061, 9980299
0.625mg, 100 count, 0046-0867-81, 8H03878, 9980299
0.625mg, 100 count, 0046-0867-81, 9D00864, 9990298
0.625mg, 1000 count, 0046-0867-91, 9D00862, 9990298
0.625mg, 1000 count, 0046-0867-91, 8H02890, 9980299

b) 2.5mg, 100 count, 0046-0865-81, 9F01554, 9990283

MANUFACTURER:
Ayerst Laboratories Inc. A Wyeth-Ayerst Company, Philadelphia, PA

RECALLED BY:
Manufacturer, by letter and fax on 12/8/00. Firm-initiated recall ongoing.

DISTRIBUTION:
NY, CA, IL.

QUANTITY:
Wyeth-Ayerst Lot #, Leiner Lot # , #of Bottles Produced
9980299, 8K01061 & 8H03878- 5916
9990298, 9D00864 & 9D00862- 27,069
9980299, 8H02890- 1800
9990283, 9F01554- 4200

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 April 12, 2001.  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!

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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.