Reported Apr 3, 2019 · Terminated
Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus…
Ingenus Pharmaceuticals LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ingenus Pharmaceuticals Llc · 4190 Millenia Blvd · Orlando, FL · 32839-6408
Is this the product you have?
- Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only
- Manufactured forIngenus Pharmaceuticals, LLC, Orlando, FL 32839-6408, NDC 50742-308-05
- Lot codes and dates
Lot #: 31804Exp 11/20193191131917Exp 02/2020320673207232084Exp 06/202032248Exp 10/2020
- Amount recalled
- 29,435 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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