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
April 28, 1999

Schein Pharmaceutical Brand Valproic Acid Capsules Recalled

PRODUCT
Schein Pharmaceutical brand Valproic Acid Capsules, USP, 250 mg, in 100 capsule bottles, Rx antiepileptic agent. NDC #0364-0822-01.
Recall #D-197-9.

CODE
Lot numbers: 93502, 93504, 93505,93694 with expiration date of 11/00.

MANUFACTURER
International Labs, Inc., St. Petersburg, Florida (repacker/responsible firm).

RECALLED BY
R.P. Scherer Corporation, St. Petersburg, Florida, by telephone on March 18, 1999, followed by fax on March 19, 1999, and courier delivery on March 22, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Undetermined.

QUANTITY
39,728 bottles were distributed.

REASON
Mislabeling - One bottle was found lacking any immediate bottle label.

 

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.