HomeDrug recalls
Medium severity

0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37

SourceFDA Drug Enforcement
CategoryDrug
SeverityMedium
Statusongoing
Recall dateOctober 27, 2025
ReportedNovember 05, 2025
Recalling firmOtsuka ICU Medical LLC
Country / regionUnited States TX

Hazard

Lack of Assurance of Sterility: Potential for flexible container leaks.

Affected products

Related recalls

Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmac · May 27, 2026Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, · May 27, 2026MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%), NET WT 6 oz (170 g), Manufacture · May 27, 2026Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, F · May 27, 2026cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), Rx ONLY, Manufactured by: UCB Inc. · May 27, 2026