Drug product
Finasteride Tablets, USP 5 mg, 90-count bottles, Rx only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs, Unit V Polepally, Jadcheria, Mahaboob Nagar - 509 301, India Limited NDC 31722-525-90
D-0453-2017
Product summary
- Event
- Event 76120
- Status
- Terminated
- Classification
- Class III
- Quantity
- 20,412 units
- Official record key
drug-enforcement:D-0453-2017
Official wording
Reason: Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.
Code information: Lot #: FIN16002, Exp. 03/2018
Distribution pattern: NJ only.
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.