FDA Drug Class II — Moderate

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.

Hazard

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

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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 Ber
Brand
DermaRite Industries, LLC
UPC
All lots on or before expiry date 08/2027

Units Affected

381,619 units

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