Drug product
Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ, 08854, NDC 31722-596-90
D-1211-2018
Product summary
- Event
- Event 81017
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5,424 bottles
- Official record key
drug-enforcement:D-1211-2018
Official wording
Reason: Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg.
Code information: Lot #: E181370, Exp. 5/2020
Distribution pattern: Indiana and Louisiana
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablet