Drug product
Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854; By: Hetero, Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India; NDC 31722-543-01.
D-1019-2018
Product summary
- Event
- Event 80589
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18,288 bottles
- Official record key
drug-enforcement:D-1019-2018
Official wording
Reason: Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
Code information: Lot #: E180315, Exp 12/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.