Product: Hydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-159-04.
Reason for recall: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Recall initiated: 20220315
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated