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
FDA recall notice · announced December 26, 2018 · Cipla Limited
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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
Reason for recall
Failed Dissolution Specifications.
Notes
Distribution: Nationwide within the United States
Lot/code information: Lot #: GG80257, Exp. 12/2019
Quantity: 4800 bottles
Status: Terminated
Products in this recall event:
- 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, (D-0382-2019)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.