Product: Hydrocortisone Butyrate Lotion, 0.1%, 4 fl oz (118 mL) bottle, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70809, NDC 70512-032-04.
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