Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Microbial contamination of non-sterile product.
Eczema Skin Relief Lotion, 2% Colloidal Oatmeal Skin Protectant Lotion, NET WT 14 OZ (396 g), NDC 65365-266-01, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895.
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 Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
Reason CGMP Deviations; product intended for quarantine was inadvertently distributed
Reason Microbial contamination of non-sterile Products -
Reason Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination
Reason Subpotent Drug: The product has failed to maintain its label claim of coal tar throughout its labeled 24-month expiry period.
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