Drug product
Nevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd. Verna Goa, India, Manufactured for: Cipla USA Inc. 9100 S Dadeland Blvd., Suite 1500 Miami, FL 33156, NDC 69097-403-02
D-0382-2019
Product summary
- Firm
- Cipla Limited
- Event
- Event 81795
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4800 bottles
- Official record key
drug-enforcement:D-0382-2019
Official wording
Reason: Failed Dissolution Specifications.
Code information: Lot #: GG80257, Exp. 12/2019
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications