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.
DermaMed Ointment, Skin Protectant, Aluminum Hydroxide Gel 2%, Net Wt. 106 g (3.75 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-214-04
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 Deviations
Reason CGMP Deviations
Reason Chemical contamination: presence of benzene
Reason CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
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