Gentell Recalls Moisture Barrier Cream Due to Manufacturing Deviations
Gentell, Inc. is recalling 65 gallons of Shield and Protect Moisture Barrier Cream because it may not meet cGMP requirements.
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: The recall is classified as FDA Class II due to GMP deviations. As no specific injuries or illnesses are reported and the hazard is related to manufacturing compliance rather than a specific acute toxin, it fits the Moderate category for voluntary precautionary or compliance-based recalls.
Plain-English summary
Gentell, Inc. is recalling 65 gallons of Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz - 115 g Anti-Fungal (NDC 61554-232-40). The product is identified by Product Code GEN-23240.
The recall was initiated due to Good Manufacturing Practice (GMP) deviations, meaning the product may not meet current Good Manufacturing Practice (cGMP) requirements. The FDA has classified this as a Class II recall.
The affected product was distributed nationwide and in Puerto Rico. Consumers should stop using the product and contact Gentell, Inc. for further instructions.
The recalled product
- Product
- Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz - 115 g Anti-Fungal, Gentell, Inc., Bristol, PA NDC 61554-232-40
- Manufacturer
- Gentell, Inc
- Category
- Drug — Topical Antifungal
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)
- Product Code GEN-23240
Distribution
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