Drug product
HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21
D-057-2013
Product summary
- Event
- Event 63138
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 14,445 bottles
- Official record key
drug-enforcement:D-057-2013
Official wording
Reason: Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Code information: Lot number: C1440512A, Exp 12/13
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
Superpotent