Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
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.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Reason CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Reason Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination
Reason Marketed without an Approved NDA/ANDA: The product may be construed a sunscreen due to labeling of the product and comments about the product found…
Reason Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Staphalococcus aureus.
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