Clotrimazole cream, 1 ounce size, recalled over good manufacturing practice deviations
Blossom Pharmaceuticals is recalling 12150 bottles of Globe Clotrimazole Cream over current good manufacturing practice deviations.
What this means for you
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%, net weight 1 oz (28.4 g), made in India, NDC 69396-087-01, 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 12150 bottles from lot A472408. 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
- Hazard
- cgmp-deviation
- manufacturing-quality
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 #: A472408
UPCs (1)
- 0094922042002
Distribution
Distributed nationwide across the United States.
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