Cipla Limited recalls Nevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd. Verna Goa, India, Ma…

Recall date

December 14, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0382-2019

FDA classification

Class II

Brand / firm

Cipla Limited

Sold / distributed

Nationwide within the United States

Why it was recalled

Failed Dissolution Specifications.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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