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U.S. Department of Health and Human Services

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