Class II · Moderate risk
Furosemide Tablets
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide.
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 100 mg added to 0.9% Sodium Chloride 100 mL Injection, 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205, 877.550.5059, barcode 70004063032.
Drug: Furosemide
- Recalling firm
- SCA Pharmaceuticals, Inc.
- Origin
- AR, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1189-2018 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. 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 II · Moderate risk
Furosemide Tablets USP
Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
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 SCA Pharmaceuticals, Inc.
All 2018 recalls
Class II · Moderate risk
VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection
Lack of Assurance of Sterility
Class II · Moderate risk
SUCcinylcholine Chloride 100 mg/5mL Injection
Lack of Assurance of Sterility
Class II · Moderate risk
SUCcinylcholine Chloride 200 mg/10mL Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Sodium Citrate 4% 3 mL
Lack of Assurance of Sterility
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