Why it was recalled
Failed Dissolution Specifications.
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
Lot numbers, UPCs & expiration codes
Lot #: GG80257, Exp. 12/2019
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0382-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 14, 2018
- FDA report date
- Dec 26, 2018
- Quantity
- 4800 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Cipla Limited
Original FDA data
Every field from FDA enforcement report D-0382-2019, exactly as published.
Show all FDA fields
- City
- Vasco Da Gama
- Status
- Terminated
- Country
- India
- Event ID
- 81795
- Address
- L129 - 146 S - 103 - 105 S - 107 - 112 L147 - L147/1/2/3 L147/A
- Code information
- Lot #: GG80257, Exp. 12/2019
- Report date
- Dec 26, 2018
- Product type
- Drugs
- Recall number
- D-0382-2019
- Classification
- Class II
- Recalling firm
- Cipla Limited
- Product quantity
- 4800 bottles
- Termination date
- Jul 8, 2020
- Reason for recall
- Failed Dissolution Specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Dec 14, 2018
- Initial firm notification
- Letter
- Center classification date
- Jan 16, 2019