Drug product
OXYCODONE HCl C-II Tablets, 5 mg USP, 100-count blister cards, Rx only, Manufactured by Nesher Pharmaceuticals USA LLC., St. Louis, MO 63044, Distributed by Major Pharmaceuticals, Livonia, MI 48150, NDC 0904-6444-61.
D-1150-2015
Product summary
- Event
- Event 71454
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,717 tablets
- Official record key
drug-enforcement:D-1150-2015
Official wording
Reason: Superpotent Drug: Confirmed customer complaint of a single unit dose blister cavity containing 2 OXYCODONE HCl 5 mg tablets.
Code information: Lot # P-20000; Exp. 08/16 Lot # P-20004; Exp. 08/16
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Superpotent