Otsuka ICU Medical recalls one lot of 0.9% Sodium Chloride injection after possible potassium chloride mix-up
Otsuka ICU Medical LLC announced a voluntary recall of a single lot of its 0.9% Sodium Chloride Injection, USP, 100 mL.
The recall was triggered after a customer complaint revealed that the overwrap labeled as sodium chloride may actually contain a 10 mEq Potassium Chloride Injection, 100 mL, from a different lot.
The company warned that accidental administration of the concentrated potassium solution could cause serious or fatal adverse events, especially in vulnerable patients such as premature infants and those on chronic parenteral nutrition. The recall is being handled at the user level.
This writeup was produced by pharmadog from original reporting by fda recalls.
Original headline: “Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection, USP Due To a Product Mix-up with 10 mEq Potassium Chloride Injection”
read at fda recalls ↗
comments(0)
5-min edit window · permanent after that