Safety Alerts Saves Lives
Safety Alerts  
 
Home Privacy About Us Contact Us Change Preferences

SafetyAlerts
August 21, 2002

Wyeth-Ayerst Has Recalled Premarin (conjugated estrogen tablets USP)

(SafetyAlerts) - The Food and Drug Administration (FDA) has released the following information.

PRODUCT
Premarin (conjugated estrogen tablets USP). 1.25 mg tablets,1000 and 5,000-tablet bottles. Recall # D-058-2.

CODE
NDC #: 0046-0866-91 (bottles of 1000)
Lot #s: 9000353, exp. 11/04 and 9000681, exp. 11/04.

RECALL EXTENDED ON 6/18/02 to the following 3 lots

NDC #: 0046-0866-81 (bottles of 100)
Lot #: 9000477, Exp. 1/05
Distribution dates: 6/12/00-8/17/01
Quantity mfr'd: 31,310 bottles
Quantity distributed: 31,310 bottles

NDC #: 0046-0866-91 (bottles of 1000)
Lot #: 9000682, Exp. 1/05
Distribution dates: 7/10/00 - 5/2/01
Quantity mfr'd: 2,160 bottles
Quantity distributed: 2,132 bottles

NDC #: 0046-0866-95 (bottles of 5000)
Lot #: 9000481, Exp. 1/05
Distribution dates: 7/6/00 - 3/13/01
Quantity mfr'd: 1,308 bottles
Quantity distributed: 1,308 bottles

----------------------------------------

RECALL EXPANDED 7/16/02: The following lots represent Batch R987005 which was manufactured January 1998.
NDC #: 0046-0866-91 (bottles of 1000)
Lot # 9980654, Exp. 1/03
Distribution dates: July 1998 - March 1999
Quantity mfr'd: 3,859 units
Quantity distributed: 3,858 units (of which 3,292 units went to wholesale customers)
NDC #: 0046-0866-95
Lot #: 9980653, Exp. 1/03
Quantity mfr'd: 1,604 units
Quantity distributed: 1,604 units (of which 648 units went to wholesale customers).

RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth-Ayerst Laboratories, Richmond, VA, by letter dated November 21, 2001.Manufacturer: Ayerst Laboratories, Inc., Rouses Point, NY.Firm initiated recall is ongoing.

REASON
Failure to meet dissolution specifications.

VOLUME OF PRODUCT IN COMMERCE
10,285 bottles.

DISTRIBUTION
Nationwide
.

 
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?

Sign-up for SafetyAlerts by Email -
The free internet newsletter that could
some day literally save your life - or
the life of someone you know.

 

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.