Skin protectant ointment recalled over contamination found at its manufacturing facility
DermaRite Industries is recalling 2,673 tubes of DermaMed Ointment because it was made at the same facility where other products and lots were found to be contaminated.
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: Scored 2 as a precautionary recall: the record cites contamination found elsewhere in the facility rather than confirmed contamination of these lots or any reported harm.
Plain-English summary
DermaMed Ointment, a skin protectant with Aluminum Hydroxide Gel 2%, in 106 g (3.75 oz) tubes, NDC 61924-214-04, from DermaRite Industries of North Bergen, New Jersey, is being recalled for a CGMP deviation.
The recall follows the product being manufactured at the same facility where other products and lots were found to be contaminated.
The recall covers 2,673 tubes across all lots with an expiry date on or before August 2027. The product was distributed nationwide in the United States. The FDA has classified the recall as Class II.
The enforcement record cites facility association rather than confirmed contamination of these lots, and reports no illnesses. Anyone holding an affected tube should follow the firm's instructions.
The recalled product
- Product
- DermaMed Ointment, Skin Protectant, Aluminum Hydroxide Gel 2%, Net Wt. 106 g (3.75 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-214-04
- Manufacturer
- DermaRite Industries, LLC
- Category
- Drug — Topical
- Hazard
- cgmp-deviation
- facility-contamination
- precautionary
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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