Renew PeriProtect Topical Cream Recalled for Manufacturing Facility Deviation
DermaRite Industries is recalling Renew PeriProtect topical cream due to current good manufacturing practice (CGMP) violations at the manufacturing facility, where other products were found contaminated.
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: This is an FDA Class II recall involving CGMP violations at a manufacturing facility where other products were found contaminated. However, no illnesses or injuries have been reported, and the source does not confirm actual contamination of the recalled product itself, making this a precautionary recall based on facility conditions.
Plain-English summary
DermaRite Industries, LLC is recalling Renew PeriProtect, a topical cream containing 12% Zinc Oxide and 1% Dimethicone, in 113-gram (4 oz.) tubes. The recall affects approximately 37,272 tubes distributed nationwide in the United States.
The recall was initiated because the manufacturing facility where Renew PeriProtect is produced did not maintain current good manufacturing practices (CGMP). Additionally, other products and lots manufactured at this same facility were found to be contaminated. This is an FDA Class II recall.
The affected product includes all lots with expiration dates on or before August 2027, identified by NDC 61924-435-04. Consumers who have purchased this product should stop using it and consult their healthcare provider if they have concerns about its safety.
Consumers with questions about this recall can contact DermaRite Industries, LLC or the FDA.
The recalled product
- Product
- Renew PeriProtect, Zinc Oxide 12%, Dimethicone 1%, 113g (4 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-435-04
- Manufacturer
- DermaRite Industries, LLC
- Category
- Drug — Topical Cream
- Hazard
- cgmp-deviation
- contamination-risk
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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