Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Microbial contamination of non-sterile Products -
BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal), 10 FL OZ/296 ML- tube, Distributed By: Prequel, LOS ANGELES, CA 90069. UPC 8 10129 11007 4
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: confirmed presence of mold contamination
Reason Microbial contamination of non-sterile product.
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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