Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manufactured by: Taro Pharmaceutica
Summary
The FDA issued a Class III for Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx o by Taro Pharmaceuticals U.S.A., Inc.. Reason: Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample.
Details
Source
Drug Recall
External ID
D-0727-2022
Action Date
2022-04-06
Status
Terminated
Category
drug
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
Lot/Code Info: Lot #: AC33883, Exp. Date June 2023
Quantity Affected: 768 tubes
Reason for Recall
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-25
Company
Hawthorne, NY
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 81 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Taro Pharmaceuticals U.S.A., Inc. has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Taro Pharmaceuticals U.S.A., Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Taro Pharmaceuticals U.S.A., Inc. have FDA actions?
Taro Pharmaceuticals U.S.A., Inc. has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0727-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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