Globe Clotrimazole Cream USP, 1 % Antifungal Cream, Net Wt., 5 oz. (142 g, Distributed by: Trifecta Pharmaceuticals USA,
Summary
The FDA issued a Class II for Globe Clotrimazole Cream USP, 1 % Antifungal Cream, Net Wt., 5 oz. (142 g, Distr by Blossom Pharmaceuticals. Reason: cGMP deviations.
Details
Source
Drug Recall
External ID
D-0211-2026
Action Date
2025-12-10
Status
Ongoing
Category
drug
Product Description
Globe Clotrimazole Cream USP, 1 % Antifungal Cream, Net Wt., 5 oz. (142 g, Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, USA, NDC 69396-087-55.
Lot/Code Info: Lot #: A472418
Quantity Affected: 14700 bottles
Reason for Recall
cGMP deviations
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-31
Company
Bardej, Goa
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 51 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Blossom Pharmaceuticals has 13 FDA actions in our database, including 13 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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 (Blossom Pharmaceuticals) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Blossom Pharmaceuticals have FDA actions?
Blossom Pharmaceuticals has 13 FDA actions in our database, including 13 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0211-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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