Drug product
Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA Inc. Bridgewater, NJ 08807, NDC 27241-120-04.
D-0611-2026
Product summary
- Event
- Event 99130
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3648 bottles
- Official record key
drug-enforcement:D-0611-2026
Official wording
Reason: CGMP Deviations
Code information: Lot # PA02216; Exp. 12/2029
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations