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
Product summary
- 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
CGMP Deviations