Drug product
Endocet (oxycodone and acetaminophen) tablets, USP, 10 mg/650 mg, 100-count tablets per bottle, Rx only, Manufactured for: Endo Pharmaceuticals Inc., Chadds Ford, PA, By: Novartis, Lincoln, NE 68501; NDC 60951-797-70.
D-1381-2012
Product summary
- Event
- Event 61791
- Status
- Terminated
- Classification
- Class III
- Quantity
- 11,764 bottles
- Official record key
drug-enforcement:D-1381-2012
Official wording
Reason: Adulterated Presence of Foreign Tablets: Customer complaint that some Endocet 10 mg/325 mg tablets were found mixed in a bottle with Endocet 10 mg/650 mg tablets.
Code information: Lot #: 402794NV, Exp 12/13
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets