Recalls / Class III
Class IIID-0146-2018
Product
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
- Brand name
- Fluocinonide
- Generic name
- Fluocinonide
- Active ingredient
- Fluocinonide
- Route
- Topical
- NDCs
- 51672-1254, 51672-1253, 51672-1279, 51672-1264
- FDA application
- ANDA072494
- Affected lot / code info
- Lot #: A771026850, Exp 6/18
Why it was recalled
Cross contamination with other products: traces of Dapsone were found in the finished product.
Recalling firm
- Firm
- Taro Pharmaceuticals U.S.A., Inc.
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Skyline Dr, N/A, Hawthorne, New York 10532-2174
Distribution
- Quantity
- 16,944 tubes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-09-20
- FDA classified
- 2017-12-29
- Posted by FDA
- 2017-11-01
- Terminated
- 2020-09-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0146-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.