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

SafetyAlerts
August 28, 2002

Recall Update: ChemSource Corporation Metformin HCl Recall is Complete

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

PRODUCT
Metformin HCl Drug Substance. Recall # D-389-2.
Strength (Purity:) HPLC: 98.0 -102.0%
Size: 50 kg
Form: Crystalline Powder
Route of Administration: will eventually be used for
oral dosage form
Rx, uses/application: Diabetes Type II
This is a bulk pharmaceutical drug

CODE
Lot no. Re-evaluation date
212001MF1 Feb 2005
212101MF1 Feb 2005
212201MF1 Feb 2005.

RECALLING FIRM/MANUFACTURER
ChemSource Corporation Guayama, Puerto Rico, by verbal notification March
27, 2002. Firm initiated recall is complete.

REASON
Potential cross contamination.

VOLUME OF PRODUCT IN COMMERCE
905.2 kg, 1,157.1 kg, 1,164.0 kg.

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.