Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay,
Summary
The FDA issued a Class I for Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pha by Taro Pharmaceuticals U.S.A., Inc.. Reason: Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria.
Details
Source
Drug Recall
External ID
D-0375-2022
Action Date
2022-01-19
Status
Terminated
Category
drug
Product Description
Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC 51672-1259-3
Lot/Code Info: Lot# AC13786, exp. date DEC 2022
Quantity Affected: 96 tubes
Reason for Recall
Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
Distribution
Two distributors in UT and LA who could have further distributed to the retail level nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-15
Company
Hawthorne, NY
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 66 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 I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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-0375-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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