Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Hydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-159-04.
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; deficiencies observed during FDA inspection
Reason CGMP Deviations; deficiencies observed during FDA inspection
Reason Subpotent Drug
Reason Subpotent Drug
Reason Subpotent Drug
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