FDA-Drug2019-04-03Class III
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.
Ingenus Pharmaceuticals Llc
Hazard
Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
Sold states
Nationwide in the USA and Puerto Rico.
Affected count
29,435 bottles
Manufactured in
4190 Millenia Blvd, N/A, Orlando, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1058-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief