drugs Class III Updated 2012-08-08

Mallinckrodt Inc. recalls Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5

Recalled Product

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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: 0375T79384, Exp 05/13; 0375T81348, Exp 09/13; 0375U82277, Exp 01/14
View official government recall

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