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Recall Observatory FDA recall evidence

Drug product

4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1%, 113g, (4 oz) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-208-04

D-0160-2026

August 27, 2025

Class II

Product summary

Firm
DermaRite Industries, LLC
Event
Event 97625
Status
Ongoing
Classification
Class II
Quantity
3,178 bottles
Official record key
drug-enforcement:D-0160-2026

Official wording

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

Code information: All lots on or before expiry date 08/2027.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviation