Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Subpotent Drug: The product has failed to maintain its label claim of coal tar throughout its labeled 24-month expiry period.
Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal, (Coal Tar 1.25%), packagedin 57 g plastic tubes, Distributed by: ALVA-AMCO Pharmacal Cos., Inc., Niles, IL 60714, USA. NDC 52389-745-56, UPC 0 72959 01045 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 -
Reason Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination
Reason Microbial contamination of non-sterile product.
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.