Recalls / Class II
Class IID-1428-2012
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.
- Affected lot / code info
- Lot #: ML9605 Exp. 10/2013
Why it was recalled
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.
Recalling firm
- Firm
- Zydus Pharmaceuticals USA Inc
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, N/A, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- 1176 Bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-03-14
- FDA classified
- 2012-07-27
- Posted by FDA
- 2012-08-08
- Terminated
- 2013-12-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1428-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.