D-0382-2019 Class II Terminated

Recalled by Cipla Limited — Vasco Da Gama

Recall Details

Product Type
Drugs
Report Date
December 26, 2018
Initiation Date
December 14, 2018
Termination Date
July 8, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4800 bottles

Product Description

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.

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: GG80257, Exp. 12/2019