Recalls / Class III
Class IIID-1370-2015
Product
Topicort (desoximetasone) Topical Spray, 0.25%, 100 mL Bottles, Rx Only. Mfd by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada, L6T 1C1, Dist by: TaroPharma, Hawthorne, NY 10532. NDC: 51672-5281-7.
- Brand name
- Topicort
- Generic name
- Desoximetasone
- Active ingredient
- Desoximetasone
- Route
- Topical
- NDC
- 51672-5281
- FDA application
- NDA204141
- Affected lot / code info
- Lot #: C4177-14965, Expiry: February 2016; Lot #: C4178-14965, Expiry: February 2016.
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6 and 9 month time points.
Recalling firm
- Firm
- Taro Pharmaceuticals, Inc.
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 130 East Dr, N/A, Brampton, N/A N/A, Canada
Distribution
- Quantity
- 16,320 Bottles
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2015-08-05
- FDA classified
- 2015-08-25
- Posted by FDA
- 2015-09-02
- Terminated
- 2017-04-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1370-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.