Enforcement Report - Week of September 5, 2012
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Product Detail
| Product Description | Leflunomide tablets, 20 mg, 1000-count bottle, Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontario Canada M9L 1T9, NDC 60505-2503-3 |
|---|---|
| Recall Number | D-1662-2012 |
| Classification | Class II |
| Code Info | Lot #: GZ1274, Exp 11/07. |
| Product Distributed Qty | 31 |
| Reason For Recall | Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications. |
Event Detail
| Event Id | 38329 |
|---|---|
| Product Type | Drugs |
| Status | Terminated |
| Recalling Firm | Apotex Corp. |
| City | Weston |
| State | FL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2007-06-14 |
| Initial Firm Notification of Consignee or Public | FAX |
| Distribution Pattern | Nationwide. |
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