Class II · Moderate risk Ongoing
Furosemide Tablets
Reason CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Furosemide Tablets USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
What was recalled
Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4297-31.
- Recalling firm
- Roxane Laboratories, Inc.
- NDC code
- 0054-4297-31
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0437-2017
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.
Other Furosemide recalls
See all
Class II · Moderate risk Ongoing
Furosemide Tablets
Reason Presence of Foreign Substance
Class I · High risk Terminated
Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection
Reason Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide.
Class II · Moderate risk Terminated
Furosemide 20 mg/mL svn Sol
Reason Lack of Assurance of Sterility
Class III · Low risk Terminated
FUROSEMIDE Tablets USP
Reason CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
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