Status
Terminated
Drug Enforcement D-1428-2012
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.
Classification
Class II
Report Date
August 8, 2012
Termination Date
December 17, 2013
Product Information
- Product description
- 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.
- Product quantity
- 1176 Bottles
- Reason for recall
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Zydus Pharmaceuticals USA Inc
- Address
-
73 Route 31 N, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1428-2012
- Event ID
- 62605
- Recall initiation date
- March 14, 2012
- Center classification date
- July 27, 2012
- Code info
- Lot #: ML9605 Exp. 10/2013
- More code info
- —