Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408, NDC 50742-308-05.

Recall Number: D-1058-2019

Firm: Ingenus Pharmaceuticals Llc

Classification: Class III

Status: Terminated

Report Date: 20190403

Initiation Date: 20190318

Termination Date: 20200306

Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.

Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408, NDC 50742-308-05.