Skin Protectant Cream Recalled Due to Manufacturing Contamination
DermaCerin Skin Protectant Moisturizing Cream is recalled nationwide due to contamination discovered at the manufacturing facility. All affected lots have expiry dates on or before August 2027.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Manufacturer issued Class II recall due to CGMP deviation with confirmed contamination detected at the manufacturing facility. While no illnesses or injuries have been reported and the specific contaminant was not identified, the product represents a potential risk of harm given the documented facility contamination.
Plain-English summary
DermaCerin Skin Protectant Moisturizing Cream containing 33% petrolatum is being recalled. The product is available in two package sizes: tubes containing 106 grams (3.75 ounces) with NDC 61924-174-04, and jars containing 454 grams (16 ounces) with NDC 61924-174-16. The product is manufactured by DermaRite Industries, LLC, located in North Bergen, New Jersey.
The FDA issued a Class II recall due to a Current Good Manufacturing Practice (CGMP) deviation. The product was manufactured at a facility where contamination was detected in other products and lots. All affected lots have expiry dates on or before August 2027 and were distributed nationwide in the United States.
Consumers who have purchased this product should discontinue use. Consumers with questions should contact the manufacturer or consult their healthcare provider for guidance regarding the affected product.
The recalled product
- Product
- DermaCerin, Skin Protectant Moisturizing Cream (petrolatum 33%), packaged in a) 106 g (3.75 oz.) per tube (NDC 61924-174-04) and b) 454 g (16 oz.) per jar (NDC 61924-174-16), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
- Manufacturer
- DermaRite Industries, LLC
- Category
- Drug — Skincare / Topical
- Hazard
- cgmp-deviation
- facility-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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