Enforcement Report - Week of July 11, 2012
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Product Detail
| Product Description | Metoprolol Tartrate Tablets USP 50 mg, 1000 count bottle, Rx only, Manufactured in india By: Emcure Pharmaceuticals LTD. Hinjwadi, Pune, India, Manufactured for TEVA Phamaceuticals USA, Sellersville, PA 18960, NDC 0093-0733-10 |
|---|---|
| Recall Number | D-1409-2012 |
| Classification | Class II |
| Code Info | Lot #TE1Y261, Exp, 12/2013 |
| Product Distributed Qty | 2,268 bottles |
| Reason For Recall | Tablet Thickness: Potential for some tablets not conforming to weight specifications (under and over weight) |
Event Detail
| Event Id | 61871 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Teva Pharmaceuticals USA, Inc. |
| City | Sellersville |
| State | PA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-05-16 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Ohio |
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