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DermaRite Industries, LLC: Lantiseptic, Skin Protectant, Lanolin USP 30%, packaged in a) 5g (0.17 oz) (NDC 61924-304-05), b)14.2g (0.5 oz)( NDC 61924-304-14), c) 4oz (

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
Lantiseptic, Skin Protectant, Lanolin USP 30%, packaged in a) 5g (0.17 oz) (NDC 61924-304-05), b)14.2g (0.5 oz)( NDC 61924-304-14), c) 4oz (NDC 61924-304-04), d) 4.5oz (NDC 61924-304-45), and e) 12oz (NDC 61924-304-12) 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
57,837 units
Voluntary mandated
Voluntary: Firm initiated
City
North Bergen
State
NJ
Country
United States
Event id
97625
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