FDA recall D-0382-2019

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.

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2018-12-14

Report date

2018-12-26

Termination date

2020-07-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Vasco Da Gama, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0382-2019