Petrolatum barrier ointment recalled over contamination found at the manufacturing facility
DermaRite Industries is recalling 381,619 units of PeriGuard Ointment because it was made at the same facility where other products and lots were found to be contaminated.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
PeriGuard Ointment, Petrolatum 49.9%, in 5 g, 3.5 oz and 7 oz tubes (NDCs 61924-205-05, -04 and -07), 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 381,619 units 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
- PeriGuard Ointment, Petrolatum 49.9%, packaged in a) 5g (NDC 61924-205-05), b) 3.5oz (NDC 61924-205-04), and c) 7oz (NDC 61924-205-07) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
- Manufacturer
- DermaRite Industries, LLC
- Category
- Drug — Topical
- Affected units
- 381,619
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.
Part of a larger recall action
This product is one of 18 recalled by DermaRite Industries, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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