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January 10, 2001

Distributor Recalls Several Lots of Premarin®

Zanesville, OH (SafetyAlerts) - The Food and Drug Administration (FDA) said today that National Pharmpak Svcs, Incorporated is recalling several lots of Premarin Conjugated because the product failed to meet USP dissolution specifications for Conjugated Estrogen.

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

Premarin Conjugated
Premarin (r) tablets (conjugated estrogens tablets),0.625 mg, 100 & 1,000 count bottles

STRENGTH: 0.625 mg/100 count bottles/NDC #0046-0867-81:

Lot #9990086    Exp. 9/02,
Lot #9990086    Exp. 12/03,
Lot #999029U    Exp. 11/03,
Lot #9990585W Exp. 11/03,
STRENGTH: 0.625 mg/1,000 count bottles/NDC #0046-0867-91:
Lot #9990086    Exp. 9/02,
Lot #9980299    Exp. 11/02;

Premarin (r) tablets (conjugated estrogens tablets), 1.25mg, 100 & 1,000 count bottles
STRENGTH 1.25 mg/100 count bottles/NDC #0046-0866-81:

Lot #9980874    Exp. 2/03;
STRENGTH: 1.25 mg/1,000 count bottles/NDC #0046-0866-91:
Lot #9980874    Exp. 2/03;

Premarin (r) tablets (conjugated estrogens tablets, 2.5mg, 100 count bottles.
STRENGTH: 2.5 mg/100 count bottles/NDC #0046-0865-81:
Lot #9990175    Exp. 10/03.

Recall #D-074/076-1.

Wyeth-Pharmaceuticals Co., Gauyama, Puerto Rico.

National Pharmpak Svcs, Incorporated, Zanesville, Ohio, by letter faxed on October 18, 2000 and December 8, 2000. Firm-initiated recall ongoing.

Nationwide and New Mexico, Puerto Rico.

108,394 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 January 10, 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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