Recalls / Class III
Class IIID-1497-2020
Product
Clobetasol Propionate Cream, USP, 0.05%, packaged in a)15g Tubes (NDC 60429-902-15) and b) 45g Tubes (NDC 60429-902-45), Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada, Marketed by: Golden State Medical Supply Inc. Camarillo, CA 93012.
- Affected lot / code info
- Lot #: a) AB28535, Exp. Date: Dec. 2021 b) AB40178, Exp. Date: Dec. 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
- Golden State Medical Supply Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5187 Camino Ruiz, N/A, Camarillo, California 93012-8601
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2020-07-24
- FDA classified
- 2020-08-13
- Posted by FDA
- 2020-08-19
- Terminated
- 2020-12-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1497-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.