Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Furosemide Injection, USP, 40 mg/4mL (10 mg/mL), 4 ml Single-Dose Vial, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-6102-04
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Reason Presence of Foreign Substance
Reason Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide.
Reason Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
Reason Lack of Assurance of Sterility
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.