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, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21 |
|---|---|
| Recall Number | D-057-2013 |
| Classification | Class I |
| Code Info | Lot number: C1440512A, Exp 12/13 |
| Product Distributed Qty | 14,445 bottles |
| Reason For Recall | Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components. |
Event Detail
| Event Id | 63138 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals |
| City | Huntsville |
| State | AL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-09-10 |
| Initial Firm Notification of Consignee or Public | Press Release |
| Distribution Pattern | Nationwide. |
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