PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: April 6, 2022 Initiated: February 25, 2022 #D-0727-2022

Product Description

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

Reason for Recall

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

Details

Units Affected
768 tubes
Distribution
Product was distributed to one retail consignee in NY.
Location
Hawthorne, NY

Frequently Asked Questions

What product was recalled?
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. Recalled by Taro Pharmaceuticals U.S.A., Inc.. Units affected: 768 tubes.
Why was this product recalled?
Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
Which agency issued this recall?
This recall was issued by the FDA Drug on April 6, 2022. Severity: Low. Recall number: D-0727-2022.