FDAClass IIIApril 3, 2019

Diclofenac Sodium Topical Solution recall

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

Why was Diclofenac Sodium Topical Solution recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current 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 #: 31804, Exp 11/2019; 31911, 31917, Exp 02/2020; 32067, 32072, 32084, Exp 06/2020; 32248, Exp 10/2020

Product
Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL…
Recalling firm
Ingenus Pharmaceuticals Llc
Quantity
29,435 bottles
Distribution
Nationwide in the USA and Puerto Rico.
Recall date
April 3, 2019
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls