Enforcement Report - Week of August 8, 2012
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Product Detail
| 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. |
|---|---|
| Recall Number | D-1428-2012 |
| Classification | Class II |
| Code Info | Lot #: ML9605 Exp. 10/2013 |
| Product Distributed Qty | 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. |
Event Detail
| Event Id | 62605 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Zydus Pharmaceuticals USA Inc |
| City | Pennington |
| State | NJ | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-03-14 |
| Initial Firm Notification of Consignee or Public | |
| Distribution Pattern | Nationwide |
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