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

Firm: Mallinckrodt Inc.

Classification: Class II

Status: Terminated

Report Date: 20120808

Initiation Date: 20120525

Termination Date: 20150417

CGMP Deviations: This product is being recalled because expired flavoring was used in the manufacturing of these lots.

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.