Drug product
Metformin Hydrochloride Tablets, USP, 1000 mg, Rx only, 1000 count tablets per Bottle, Manufactured by: Cadila Healthcare LTD. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-030-10.
D-1428-2012
Product summary
- Event
- Event 62605
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1176 Bottles
- Official record key
drug-enforcement:D-1428-2012
Official wording
Reason: Presence of Foreign Substance(s): A product complaint was received from a pharmacist who discovered that several tablets displayed brown specks. The same complainant also reported that metal shaving like material was observed on the surface of one tablet.
Code information: Lot #: ML9605 Exp. 10/2013
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance