Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Subpotency: one product for active ingredient assay and another one for preservative assay
Hydroquinone, USP, 4% Skin Bleaching Cream, packaged in 1 oz (28.35g) tube, Rx only, Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN 37217, NDC 69367-174-01 UPC 3 69367 17401 5
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 Finished product specification did not meet USP specifications.
Reason GMP Deviations
Reason Lack of Processing Control
Reason CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good…
Reason Failed Stability Specifications: Out-of-specification for viscosity, pH and specific gravity
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