Home / Recalls / Cipla Limited / D-0382-2019

D-0382-2019 Class II Terminated

Recalled by Cipla Limited — Vasco Da Gama

FDA drug recall D-0382-2019 was initiated by Cipla Limited on Dec 14, 2018 and is designated Class II. Reason for recall: Failed Dissolution Specifications. The recall status is terminated (terminated Jul 8, 2020). Affected quantity: 4800 bottles.

Recall Details

Product Type: Drugs
Report Date: Dec 26, 2018
Initiation Date: Dec 14, 2018
Termination Date: Jul 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

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0382-2019
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.