Recalls / Class II
Class IID-0116-2017
Product
Desoximetasone Cream USP, 0.25% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532; NDC 51672-1270-7
- Brand name
- Desoximetasone
- Generic name
- Desoximetasone
- Active ingredient
- Desoximetasone
- Route
- Topical
- NDCs
- 51672-1261, 51672-1271, 51672-1270
- FDA application
- ANDA074904
- Affected lot / code info
- Lot #: B5093-18608, B5094-18608, Exp. Jan 2017; Lot #: C5141-18954, C5142-18954, E5109-19625, Exp . Feb 2017
Why it was recalled
Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
Recalling firm
- Firm
- Taro Pharmaceuticals, Inc.
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 130 East Dr, Brampton, N/A, Canada
Distribution
- Quantity
- 15,576 units
- Distribution pattern
- US & Puerto Rico
Timeline
- Recall initiated
- 2016-09-13
- FDA classified
- 2016-11-01
- Posted by FDA
- 2016-11-09
- Terminated
- 2018-06-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0116-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.