FDA Recall Terminated Historical recordClass II
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
- cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- Published
- March 30, 2022
- Distribution
- Nationwide
