Drug recall D-0143-2026
Product
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Reason for recall
Lack of Assurance of Sterility: Potential for flexible container leaks.
Lots and codes
Lot # 1029921, Exp Date: 28 February 2027
Recall details
- Recalling firm
- Otsuka ICU Medical LLC, Austin, TX
- Quantity
- 509,360 100 mL bags
- Distribution
- Distributed Nationwide in the USA.
- Type
- Voluntary: Firm initiated
- Recall initiated
- October 27, 2025
Related products
- Sodium Chloride – drug information
- NDC 0990-7730 Sodium Chloride · Sodium Chloride 450 mg/100mL · ICU Medical Inc.
- NDC 0990-7984 Sodium Chloride · Sodium Chloride 900 mg/100mL · ICU Medical Inc.
- NDC 0990-7983 Sodium Chloride · Sodium Chloride 900 mg/100mL · ICU Medical Inc.
- NDC 0990-7985 Sodium Chloride · Sodium Chloride 450 mg/100mL · ICU Medical Inc.