PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: December 22, 2021 Initiated: November 29, 2021 #D-0278-2022

Product Description

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

Reason for Recall

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

Details

Units Affected
72 bottles
Distribution
Distributed to 5 physician consignees located in the following states: CT, FL, and KS.
Location
Anaheim, CA

Frequently Asked Questions

What product was recalled?
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. Recalled by Preferred Pharmaceuticals, Inc.. Units affected: 72 bottles.
Why was this product recalled?
Defective container: Out of specification for container integrity leading to bottles leaking.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 22, 2021. Severity: Moderate. Recall number: D-0278-2022.