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-1430-2012
Product summary
- Event
- Event 61967
- Status
- Terminated
- Classification
- Class III
- Quantity
- 41,100 bottles
- Official record key
drug-enforcement:D-1430-2012
Official wording
Reason: Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone bitartrate ingredient was found.
Code information: Lot #: 0375T79384, Exp 05/13; 0375T81348, Exp 09/13; 0375U82277, Exp 01/14
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent