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

Recall Summary Otsuka ICU Medical LLC is recalling one lot of 0.9% Sodium Chloride Injection (a saline solution) because some units may have been mislabeled and could actually contain potassium chloride instead. The affected product is lot 1042188 in 100mL single packs with NDC number 0990-7984-23. This recall applies to all facilities and users who received this lot.

Recalling firm
Otsuka ICU Medical LLC
Product
0.9% Sodium Chloride Injection, USP
Reason
Otsuka ICU Medical LLC is issuing a voluntary recall for one lot of 0.9% SODIUM CHLORIDE Injection, USP, 100mL single pack to the user level due to a potential mix-up. The affected lot of 0.9% SODIUM CHLORIDE Injection, USP (NDC: 0990-7984-23 Lot 1042188) may potentially contain the overwrap with la
Category
drug recall
Country
United States
Agency
FDA-MEDWATCH-RSS
Recall date
2026-09-21
Status
Ongoing

Official recall notice from FDA-MEDWATCH-RSS

Recall details on Nibble Recalls: https://trynibble.app/recalls/0071df3f-ce9b-43cd-9c40-34c7b91f51ad