Recalls / Class III
Class IIID-0790-2017
Product
Fluocinonide Cream UPS, 0.05% (Emulsified Base), packaged in 60 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1254-3
- 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 #: D301311473, D301411473, Exp 3/2017
Why it was recalled
Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate.
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, Hawthorne, New York 10532-2174
Distribution
- Quantity
- 7,776 tubes
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2017-03-17
- FDA classified
- 2017-05-18
- Posted by FDA
- 2017-05-24
- Terminated
- 2021-08-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0790-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.