FDAClass IIMarch 30, 2022

Diclofenac Sodium Topical Solution 1.5% recall

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

Why was Diclofenac Sodium Topical Solution 1.5% recalled?

Defective Container: Leaking containers.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 24MA2010 Exp. 1/31/2023

Product
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
Recalling firm
Direct Rx
Quantity
312 bottles
Distribution
Nationwide within the United States
Recall date
March 30, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls