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
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: GG80257, Exp. 12/2019
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Cipla Limited
- Reason for Recall:
- Failed Dissolution Specifications.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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
Product Codes/Lot Numbers:
Lot #: GG80257, Exp. 12/2019
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0382-2019
Related Recalls
Failed Stability Specifications: Observed OOS results: eg results for colour index
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.