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
Reported: December 26, 2018 Initiated: December 14, 2018 #D-0382-2019
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.
Details
- Recalling Firm
- Cipla Limited
- Units Affected
- 4800 bottles
- Distribution
- Nationwide within the United States
- Location
- Vasco Da Gama
Frequently Asked Questions
What product 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. Recalled by Cipla Limited. Units affected: 4800 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 26, 2018. Severity: Moderate. Recall number: D-0382-2019.
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