Why it was recalled
Cross contamination with other products: traces of Dapsone were found in the finished product.
Product description
Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton Ontario Canada L6T1C1, Dist. by: Taro Pharmaceuticals U.S.A . Inc. Hawthorne NY 10532, NDC 51672-1279-1
Lot numbers, UPCs & expiration codes
Lot #: A771026850, Exp 6/18
Where it was sold
Nationwide
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-0146-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 20, 2017
- FDA report date
- Nov 1, 2017
- Quantity
- 16,944 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
Original FDA data
Every field from FDA enforcement report D-0146-2018, exactly as published.
Show all FDA fields
- City
- Hawthorne
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 78157
- Address
- 3 Skyline Dr
- Code information
- Lot #: A771026850, Exp 6/18
- Postal code
- 10532-2174
- Report date
- Nov 1, 2017
- Product type
- Drugs
- Recall number
- D-0146-2018
- Classification
- Class III
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- Product quantity
- 16,944 tubes
- Termination date
- Sep 10, 2020
- Reason for recall
- Cross contamination with other products: traces of Dapsone were found in the finished product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton Ontario Canada L6T1C1, Dist. by: Taro Pharmaceuticals U.S.A . Inc. Hawthorne NY 10532, NDC 51672-1279-1
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 20, 2017
- Initial firm notification
- Letter
- Center classification date
- Dec 29, 2017