Home / Recalls / Mallinckrodt Inc. / D-1430-2012

D-1430-2012 Class III Terminated

Recalled by Mallinckrodt Inc. — Hobart, NY

Recall Details

Product Type
Drugs
Report Date
August 8, 2012
Initiation Date
May 25, 2012
Termination Date
April 17, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
41,100 bottles

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.

Reason for Recall

Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone bitartrate ingredient was found.

Distribution Pattern

Nationwide

Code Information

Lot #: 0375T79384, Exp 05/13; 0375T81348, Exp 09/13; 0375U82277, Exp 01/14

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