DermaRite 4-N-1 Skin Protectant Recalled for Manufacturing Facility Deviation
DermaRite Industries recalls 4-N-1 Skin Protectant nationwide due to manufacturing facility contamination. Consumers should stop using the product.
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 precautionary recall due to facility contamination history. No specific pathogen identified and no reported illnesses, fitting the Moderate severity criteria.
Plain-English summary
DermaRite Industries, LLC is recalling all lots of 4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1%, 113g bottles (NDC 61924-208-04). This recall affects 3,178 bottles.
The recall was initiated due to a Current Good Manufacturing Practice (CGMP) deviation discovered at the manufacturing facility. The facility where this product was manufactured has also been identified as the location where other products and lots were previously found to be contaminated.
This product was distributed nationwide throughout the United States. Consumers who have purchased this product should discontinue use immediately.
Consumers with questions, or those who believe they may have been exposed to a contaminated product, should contact their healthcare provider or poison control center.
The recalled product
- Product
- 4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1%, 113g, (4 oz) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-208-04
- Manufacturer
- DermaRite Industries, LLC
- Category
- Drug — Topical / Skin Protectant
- Hazard
- contamination
- manufacturing-deviation
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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