FDA-Drug2022-04-06Class III

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

Taro Pharmaceuticals U.S.A., Inc.
Hazard

Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample

Sold states
Product was distributed to one retail consignee in NY.
Affected count
768 tubes
Manufactured in
3 Skyline Dr, N/A, Hawthorne, NY, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0727-2022

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