PlainRecalls
FDA Drug Moderate Class II Terminated

Diclofenac Sodium Topical Solution 1.5% w/w, Generic for Pennsaid, 150 ml bottle, Rx Only, Mfg: Sola Pharmaceutical, Preferred Pharmaceuticals, Inc., The Physicians Solutions, NDC 68788-7918-01

Reported: April 27, 2022 Initiated: March 24, 2022 #D-0773-2022

Product Description

Diclofenac Sodium Topical Solution 1.5% w/w, Generic for Pennsaid, 150 ml bottle, Rx Only, Mfg: Sola Pharmaceutical, Preferred Pharmaceuticals, Inc., The Physicians Solutions, NDC 68788-7918-01

Reason for Recall

CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.

Details

Units Affected
528 bottles
Distribution
Nationwide within the USA.
Location
Anaheim, CA

Frequently Asked Questions

What product was recalled?
Diclofenac Sodium Topical Solution 1.5% w/w, Generic for Pennsaid, 150 ml bottle, Rx Only, Mfg: Sola Pharmaceutical, Preferred Pharmaceuticals, Inc., The Physicians Solutions, NDC 68788-7918-01. Recalled by Preferred Pharmaceuticals, Inc.. Units affected: 528 bottles.
Why was this product recalled?
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 27, 2022. Severity: Moderate. Recall number: D-0773-2022.