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

spacer.gif (43 bytes)

FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
November 11, 1998

PRODUCT
Premarin Tablets (Conjugated Estrogens Tablets, USP), 1.25 mg, in bottles of 100. Recall #D-012-9.

CODE
Lot number 8G01759.

MANUFACTURER
Ayerst-Wyeth Pharmaceuticals, Inc., Guayama, RQ.

RECALLED BY
Leiner Health Products, Madison, Wisconsin, by letter on September 15, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
16,004 bottles were distributed.

REASON
Mislabeling - One bottle labeled by Leiner Health Products as Premarin 1.25 mg tablets actually contained Buspar 10 mg tablets (Buspirone HCL USP).

 

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.