FDA DrugClass II

Renew Skin Repair Cream, Dimethicone 1.5%, packaged in a) 5g tube (NDC 61924-405-05), b) 4 oz tube (NDC 61924-405-04), and c) 800 mL (NDC 61924-405-27), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

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

From the FDA notice · Read the official notice ↗

What to do

The agency's notice has the remedy and who to contact.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Renew Skin Repair Cream, Dimethicone 1.5%, packaged in a) 5g tube (NDC 61924-405-05), b) 4 oz tube (NDC 61924-405-04), and c) 800 mL (NDC 61924-405-27), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 18 products — see all of them.

Details

Units affected
57,041 units
Illnesses reported
None reported
Manufactured in
7777 W Side Ave, North Bergen, NJ, United States
Classification
Class II
Recall number
D-0175-2026

In the FDA's words

Description
Renew Skin Repair Cream, Dimethicone 1.5%, packaged in a) 5g tube (NDC 61924-405-05), b) 4 oz tube (NDC 61924-405-04), and c) 800 mL (NDC 61924-405-27), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. All lots on or before expiry date 08/2027 Distribution: Nationwide in the USA Affected quantity: 57,041 units
Hazard
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

18 products in this recall

DermaRite skin and sanitizer products recalled for contamination

DermaRite Industries is recalling 18 skin care, antiseptic, hand sanitizer, and antiperspirant products sold nationwide, including the McKesson Skin Protectant distributed by McKesson. The recall was filed because of manufacturing quality problems, and other products and lots made at the same facility were found to be contaminated. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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