Warning
Leading Pharma Recalls Furosemide Tablets
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0486-2026Drug / Pharmaceutical
Leading Pharma Recalls Furosemide Tablets
Leading Pharma, LLC · Class II — Moderate Risk
Product Description
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01
Reason for Recall
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
US Nationwide.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database