Class I — High risk. Reasonable probability of serious harm or death.
Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%), NET WT 6 oz (170 g), Manufactured by: Pharmacal 1 Pharmacal Way, P.O. Box 198, Jackson, WI 53037.
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 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 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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