Ingenus Pharmaceuticals Llc recalls Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus Pharmaceuti…

Recall date

March 18, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1058-2019

FDA classification

Class III

Brand / firm

Ingenus Pharmaceuticals Llc

Sold / distributed

Nationwide in the USA and Puerto Rico.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.