CGMP/Finished Pharmaceuticals/Adulterated
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Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 20 mEq Potassium Chloride Injection Due To Overwrap Mislabeled As 10 mEq Potassium Chloride Injection
FOR IMMEDIATE RELEASE – October 31, 2025 AUSTIN, TX – Otsuka ICU Medical LLC is issuing a voluntary recall to the user level, for a MISLABELLED lot of POTASSIUM CHLORIDE Inj. 20 mEq, NDC 0990-7077-14. The OVERWRAP label of lot 1030613, Expiration Date: 09-30-2026 may incorrectly identify the productEarly Alert: Infusion Pump Software Issue from Baxter
This communication is part of the Communications Pilot to Enhance the Medical Device Recall ProgramDrug Safety Oversight Board
The DSB is composed of representatives from two FDA Centers and eight other federal government agencies, the Agency for Healthcare Research and Quality, Centers for Disease Control and Prevention, Centers for Medicare and Medicaid Services, Department of Defense.Jubilant HollisterStier General Partnership – 6/14/2024
Jubilant HollisterStier General Partnership – 6/14/2024. Country: Canada. Record Type: 483Infusion Pump Recall: Zyno Medical Removes Certain Z-800 Series Infusion Pumps due to Software Issue
Infusion pumps released with incorrect software can experience unexpected performance problems, including issues with essential functions and risk measures.Novel Drug Approvals for 2024
Innovative drugs often mean new treatment options for patients and advances in health care for the American public.
