Mallinckrodt Inc. recalls Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mall
Recalled August 8, 2012 · FDA recall D-1431-2012 · Mallinckrodt
Hazard
CGMP Deviations: This product is being recalled because expired flavoring was used in the manufacturing of these lots. · FDA Class II
Units
44,330 bottles
Sold at
Nationwide
Description
CGMP Deviations: This product is being recalled because expired flavoring was used in the manufacturing of these lots.
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.
Manufacturer(s)
Mallinckrodt Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →