United StatesFurosemide Tablets, USP 80 mg in 100‑tablet prescription bottles (NDC 69315‑118‑01) manufactured by Leading Pharma, LLC, Fairfield NJ — lots H03125, H03225, H03325, exp. 2027/08 — sold nationwide in the US are affected. The product was recalled due to cGMP deviations and the presence of N‑nitroso‑Furosemide (NNF) above the recommended intake limit.
What's being recalled
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01
Recalling firm: Leading Pharma, LLC, Fairfield, NJ, United States.
How to identify it
Lots# H03125, H03225, H03325, Exp Date: 2027/08
The hazard
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)