Enforcement Report - Week of August 8, 2012
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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 |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| 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. | Lot #: 0375T79384, Exp 05/13; 0375T81348, Exp 09/13; 0375U82277, Exp 01/14 | Class III | Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone bitartrate ingredient was found. | 41,100 bottles | D-1430-2012 |
| 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. | Lot #: 0375P76192, Exp 07/12; 0375T80512, Exp 08/13; 0375T81209, Exp 09/13 | Class II | CGMP Deviations: This product is being recalled because expired flavoring was used in the manufacturing of these lots. | 44,330 bottles | D-1431-2012 |
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