Enforcement Report - Week of June 20, 2012
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Product Detail
| Product Description | Endocet (oxycodone and acetaminophen) tablets, USP, 10 mg/650 mg, 100-count tablets per bottle, Rx only, Manufactured for: Endo Pharmaceuticals Inc., Chadds Ford, PA, By: Novartis, Lincoln, NE 68501; NDC 60951-797-70. |
|---|---|
| Recall Number | D-1381-2012 |
| Classification | Class III |
| Code Info | Lot #: 402794NV, Exp 12/13 |
| Product Distributed Qty | 11,764 bottles |
| Reason For Recall | Adulterated Presence of Foreign Tablets: Customer complaint that some Endocet 10 mg/325 mg tablets were found mixed in a bottle with Endocet 10 mg/650 mg tablets. |
Event Detail
| Event Id | 61791 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Endo Pharmaceuticals, Inc. |
| City | Chadds Ford |
| State | PA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-05-07 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide and Puerto Rico |
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