Class II · Moderate risk
Furosemide Tablets
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.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4297-31.
Affected NDC
0054-4297-31
Compare with the code on your package — it is the most precise check available.
Drug: Furosemide
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Furosemide NDC 00054-4297 |
20 mg/1 | Tablet Oral |
Hikma Pharmaceuticals USA Inc. | Rx |
- 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 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Furosemide recalls
See all
Class II · Moderate risk
Furosemide Tablets
Presence of Foreign Substance
Class I · High risk
Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection
Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide.
Class II · Moderate risk
Furosemide 20 mg/mL svn Sol
Lack of Assurance of Sterility
Class III · Low risk
FUROSEMIDE Tablets USP
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.
Other recalls by Roxane Laboratories, Inc.
All 2016 recalls
Class III · Low risk
Azelastine Hydrochloride Nasal Solution
Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.