Enforcement Report - Week of August 8, 2012
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Product Detail
| Product Description | Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mallinckrodt Inc., Hazelwood, MO 63042 USA, NDC 0406-0375-16, UPC 3 0406-0375-16 1. |
|---|---|
| Recall Number | D-1431-2012 |
| Classification | Class II |
| Code Info | Lot #: 0375P76192, Exp 07/12; 0375T80512, Exp 08/13; 0375T81209, Exp 09/13 |
| Product Distributed Qty | 44,330 bottles |
| Reason For Recall | CGMP Deviations: This product is being recalled because expired flavoring was used in the manufacturing of these lots. |
Event Detail
| Event Id | 61967 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Mallinckrodt Inc. |
| City | Hobart |
| State | NY | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-05-25 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide |
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