Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Finished product specification did not meet USP specifications.
Hydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN 37217 NDC 69367-174-01
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 Subpotency: one product for active ingredient assay and another one for preservative assay
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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