Diclofenac Sodium Topical Solution 1.5%, 150 mL, Rx only, Packaged and Distributed by: Direct Rx ...
FDA Recall #D-0714-2022 — Class II — December 7, 2021
Product Description
Diclofenac Sodium Topical Solution 1.5%, 150 mL, Rx only, Packaged and Distributed by: Direct Rx Dawsonville, GA 30534 Mfg. For SOLA Pharmaceuticals Baton Rouge, LA, NDC 61919-675-05
Reason for Recall
Defective Container: Leaking containers.
Recalling Firm
Direct Rx — Dawsonville, GA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
312 bottles
Distribution
Nationwide within the United States
Code Information
Lot #: 24MA2010 Exp. 1/31/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated