FDA-Drug2025-11-26Class II

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.

DermaRite Industries, LLC
Hazard

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Sold states
Nationwide in the USA
Affected count
381,619 units
Manufactured in
7777 W Side Ave, North Bergen, NJ, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0173-2026

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