Blemish Spot Treatment
Reason Failed Stability Specifications
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Superpotent Drug: Salicylic acid content is above the firm's specification.
PCA Skin Blemish Control Bar, 3.2 oz/90g, Salicylic acid 2% - Acne cleanser, For external use only, Distributed by PCA Skin, 6210 E. Thomas Rd., Ste. 200, Scottsdale, AZ 85251; UPC 812025010397.
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 abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.
Reason CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
Reason cGMP Deviations
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