Nevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd...
FDA Recall #D-0382-2019 — Class II — December 14, 2018
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.
Recalling Firm
Cipla Limited — Vasco Da Gama
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
4800 bottles
Distribution
Nationwide within the United States
Code Information
Lot #: GG80257, Exp. 12/2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated