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Recall Observatory FDA recall evidence

Drug 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.

D-1431-2012

May 25, 2012

Class II

Product summary

Firm
Mallinckrodt Inc.
Event
Event 61967
Status
Terminated
Classification
Class II
Quantity
44,330 bottles
Official record key
drug-enforcement:D-1431-2012

Official wording

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

Code information: Lot #: 0375P76192, Exp 07/12; 0375T80512, Exp 08/13; 0375T81209, Exp 09/13

Distribution pattern: Nationwide

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations