Product: Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottles, Rx Only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-025-05.
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