Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations
Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50), and b) 100 g can (NDC 50742-304-01), Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408.
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 CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason Subpotent Drug: Low assay result observed during long-term stability testing.
Reason CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability…
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