Blemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Script, Chandler, AZ 85226, UPC 6 10563 13873 9.
Reason Failed Stability Specifications
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
Skin Medica Acne System, Contains: Purifying Foaming Wash (Salicylic Acid 2.0%), 5 fl oz.; Purifying Toner (Salicylic Acid 2.0%), 6 fl oz,; Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 fl oz., Distributed in the U.S.A. by Allergan, Irvine, CA 92612, UPC 300234966005
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 Failed Stability Specifications
Reason CGMP Deviations
Reason cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an…
Reason CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
Reason cGMP Deviations
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