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DermaRite Industries, LLC: 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

DrugsSource: FDA (drug) · Date: 2025-11-26

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
DermaRite Industries, LLC
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.
Reason / hazard
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide in the USA
Recall initiated
2025-08-27
Code info
All lots on or before expiry date 08/2027
Product quantity
381,619 units
Voluntary mandated
Voluntary: Firm initiated
City
North Bergen
State
NJ
Country
United States
Event id
97625
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