Recalls / Class III
Class IIID-0727-2022
Product
Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manufactured by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4048-1
- Brand name
- Clotrimazole And Betamethasone Dipropionate
- Generic name
- Clotrimazole And Betamethasone Dipropionate
- Active ingredients
- Betamethasone Dipropionate, Clotrimazole
- Route
- Topical
- NDC
- 51672-4048
- FDA application
- ANDA075673
- Affected lot / code info
- Lot #: AC33883, Exp. Date June 2023
Why it was recalled
Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
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
- 768 tubes
- Distribution pattern
- Product was distributed to one retail consignee in NY.
Timeline
- Recall initiated
- 2022-02-25
- FDA classified
- 2022-03-29
- Posted by FDA
- 2022-04-06
- Terminated
- 2024-09-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0727-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.