San-E-Foam Antiseptic Foam Recalled Due to Facility Contamination
San-E-Foam antiseptic foam is recalled due to manufacturing facility contamination. All lots through August 2027 distributed nationwide are affected.
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: FDA Class II recall with CGMP deviation and potential facility contamination. No illnesses or injuries are reported and contamination is not confirmed in this product, making this a precautionary recall.
Plain-English summary
DermaRite Industries, LLC is recalling San-E-Foam, an alcohol-based antiseptic foam containing 67% alcohol in 1000 mL cartridges. The product is identified by NDC 61924-107-34.
The recall is due to a Current Good Manufacturing Practice (CGMP) deviation. The product was manufactured at a facility where other products and lots have been found to be contaminated.
All lots of this product with expiration dates on or before August 2027 are affected. The product was distributed nationwide in the USA, with 15,465 cartridges involved in the recall.
Consumers and healthcare facilities should stop using affected cartridges. For instructions regarding this recall, contact DermaRite Industries, LLC.
The recalled product
- Product
- San-E-Foam, Alcohol 67%, 1000 mL (34 fl. oz.) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-107-34
- Manufacturer
- DermaRite Industries, LLC
- Category
- Drug — Antiseptic / Sanitizer
- Hazard
- contamination
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)
- All lots on or before expiry date 08/2027
Distribution
Distributed nationwide across the United States.
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