Enforcement Report - Week of February 6, 2013
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Product Detail
| Product Description | Carvedilol Tablets, USP, 12.5 mg, 500-count tablets per bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-3633-05, UPC 3 0378-3633-05 3. |
|---|---|
| Recall Number | D-137-2013 |
| Classification | Class II |
| Code Info | Lot #: ZCMH12031, ZCMH12032, ZCMH12033, ZCMH12034, Exp 02/14 |
| Product Distributed Qty | 11,580 bottles |
| Reason For Recall | Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness. |
Event Detail
| Event Id | 64154 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Mylan Pharmaceuticals Inc. |
| City | Morgantown |
| State | WV | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2013-01-16 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide. |
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