FUROSEMIDE

Generic: FUROSEMIDE

Chartwell RXManufacturer

ORALRoute

FUROSEMIDEActive Substance

1983-11-30Original Approval

FUROSEMIDE is FDA application NDA018413, sponsored by CHARTWELL RX. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2013-02-26

Furosemide Injection, USP, 40 mg/4mL (10 mg/mL), 4 ml Single-Dose Vial, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA

Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.

Class II2013-01-10

Furosemide Injection USP (10 mg/mL), 4 mL in 5 mL Fliptop Vial, Rx only, Hospira Inc., Lake Forest, IL --- NDC 0409-6102

Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial

Class II2026-03-20

Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004,

CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.

Class III2015-09-25

FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories

CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solu

Class II2026-01-10

Furosemide Tablets, USP 40 mg, 1,000 Tablets, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., East Brunswick, NJ

Presence of Foreign Substance

Class III2015-09-25

FUROSEMIDE Tablets USP, 40 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories

CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solu

Class II2016-12-22

Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4

Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.

FUROSEMIDE

Recalls

Top Reported Reactions