Class I · High risk Ongoing
MG217 Multi-Symptom Treatment Cream & Skin Protectant
Reason Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent Drug: The product has failed to maintain its label claim of coal tar throughout its labeled 24-month expiry period.
What was recalled
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.
- Recalling firm
- Alva-Amco Pharmacal Companies., Inc.
- NDC code
- 52389-745-56
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0589-2018
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.
Other Oatmeal recalls
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Class II · Moderate risk Ongoing
First Aid Beauty Ultra Repair Cream
Reason CGMP Deviations; product intended for quarantine was inadvertently distributed
Class II · Moderate risk Ongoing
Barrier Therapy Skin Protectant Cream
Reason Microbial contamination of non-sterile Products -
Class II · Moderate risk Ongoing
Oatmeal Daily Moisturizing Body Lotion
Reason Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination
Class III · Low risk Terminated
Eczema Skin Relief Lotion
Reason Microbial contamination of non-sterile product.
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