Clotrimazole cream, 5 ounce size, recalled over good manufacturing practice deviations
Blossom Pharmaceuticals is recalling 14700 bottles of Globe Clotrimazole Cream USP over current good manufacturing practice deviations.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites current good manufacturing practice deviations with no stated product defect or reported harm.
Plain-English summary
Globe Clotrimazole Cream USP, 1% Antifungal Cream, net weight 5 oz (142 g), NDC 69396-087-55, distributed by Trifecta Pharmaceuticals USA of Ft. Lauderdale, Florida, is being recalled.
The reason given in the enforcement record is cGMP deviations.
The recall covers 14700 bottles from lot A472418. Distribution was nationwide in the USA. The FDA has classified the action as Class II.
The record cites manufacturing practice deviations without describing a specific product defect, and states no injuries. Customers should follow the firm's instructions.
The recalled product
- Product
- CLOTRIMAZOLE (CLOTRIMAZOLE)
- Brand
- CLOTRIMAZOLE
- Manufacturer
- Blossom Pharmaceuticals
- Category
- Drug — Antifungal
- Affected units
- 14,700
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #: A472418
UPCs (1)
- 0094922042002
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by Blossom Pharmaceuticals under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 13 products in this recall →Related recalls
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