Class II
Terminated
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.
This recall has been terminated (originally issued August 8, 2012).
- Company
- Zydus Pharmaceuticals (Usa) Inc
- Recall Initiated
- March 14, 2012
- Posted
- August 8, 2012
- Recall Number
- D-1428-2012
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1176 Bottles
- Firm Location
- Pennington, NJ, United States
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide
Lot / Code Info
Lot #: ML9605 Exp. 10/2013
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