FDAClass IIDecember 22, 2021

Diclofenac Sodium Topical Solution recall

Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx only, Mfg: SOLA Pharmaceuticals Preferred Pharmaceuticals, Inc., NDC 68788-7707-01

Why was Diclofenac Sodium Topical Solution recalled?

Defective container: Out of specification for container integrity leading to bottles leaking.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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 #: E1220B

Product
Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx only, Mfg: SOLA Pharmaceuticals Preferred Pharmaceuticals, Inc., NDC 68788-7707-01
Recalling firm
Preferred Pharmaceuticals, Inc.
Quantity
72 bottles
Distribution
Distributed to 5 physician consignees located in the following states: CT, FL, and KS.
Recall date
December 22, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls