Class I — High risk. Reasonable probability of serious harm or death.
Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide.
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.
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 Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Reason shortfill; reports of empty capsules.
Reason Presence of Particulate Matter: Hair was found in products
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
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