PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: March 30, 2022 Initiated: December 7, 2021 #D-0714-2022

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.

Details

Recalling Firm
Direct Rx
Units Affected
312 bottles
Distribution
Nationwide within the United States
Location
Dawsonville, GA

Frequently Asked Questions

What product was recalled?
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. Recalled by Direct Rx. Units affected: 312 bottles.
Why was this product recalled?
Defective Container: Leaking containers.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 30, 2022. Severity: Moderate. Recall number: D-0714-2022.