Recalls / Class II
Class IID-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
- Affected lot / code info
- Lot #: GG80257, Exp. 12/2019
Why it was recalled
Failed Dissolution Specifications.
Recalling firm
- Firm
- Cipla Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- L129 - 146 S - 103 - 105 S - 107 - 112 L147 - L147/1/2/3 L147/A, Vasco Da Gama, N/A, India
Distribution
- Quantity
- 4800 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2018-12-14
- FDA classified
- 2019-01-16
- Posted by FDA
- 2018-12-26
- Terminated
- 2020-07-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0382-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.