August 28, 2002
Recall Update: ChemSource Corporation Metformin
HCl Recall is Complete
- The Food and Drug Administration (FDA)
has released the
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
Lot no. Re-evaluation date
212001MF1 Feb 2005
212101MF1 Feb 2005
212201MF1 Feb 2005.
ChemSource Corporation Guayama, Puerto Rico, by verbal notification March
27, 2002. Firm initiated recall is complete.
Potential cross contamination.
VOLUME OF PRODUCT IN COMMERCE
905.2 kg, 1,157.1 kg, 1,164.0 kg.