Recall: D-0727-2022

Class III - Minor Violations

Class IIIClassification

2022-02-25Initiated

TerminatedStatus

Taro Pharmaceuticals U.S.A., IFirm

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

Reason

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

Distribution

Product was distributed to one retail consignee in NY.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.