Recalls / Class III
Class IIID-1496-2020
Product
Clobetasol Propionate Cream USP, 0.05%, a) 15 g tube, NDC: 60429-902-15; b) 45 g tube, NDC: 60429-902-45, Rx Only, For External Use Only, Not for Ophthalmic Use, Mfd by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Marketed by: Golden State Medical Supply, Inc. Camarillo, CA 93012.
- Affected lot / code info
- a) AB28353, Exp 12/31/2021; b) AB40178, Exp 12/31/2021
Why it was recalled
Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Recalling firm
- Firm
- Taro Pharmaceuticals U.S.A., Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Skyline Dr, N/A, Hawthorne, New York 10532-2174
Distribution
- Quantity
- 7632 tubes
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2020-07-20
- FDA classified
- 2020-08-12
- Posted by FDA
- 2020-08-19
- Terminated
- 2023-06-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1496-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.