Enforcement Report - Week of November 28, 2012
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Product Detail
| Product Description | Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 00591-0540-05. |
|---|---|
| Recall Number | D-058-2013 |
| Classification | Class I |
| Code Info | Lot #: 519406A, 521759A, Exp 04/14 |
| Product Distributed Qty | 4,874 bottles |
| Reason For Recall | Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets. |
Event Detail
| Event Id | 63246 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Watson Laboratories Inc |
| City | Corona |
| State | CA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-09-21 |
| Initial Firm Notification of Consignee or Public | Press Release |
| Distribution Pattern | Nationwide |
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