Drug recall D-0347-2023
Product
0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-10
Reason for recall
Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.
Lots and codes
Lots: 0061794230 Exp. 01/31/2024; 0061794232 Exp. 01/31/2024; 0061797779 Exp. 02/29/2024; 0061797780 Exp. 02/29/2024; 0061797781 Exp. 02/29/2024; 0061797783 Exp. 02/29/2024; 0061797784 Exp. 03/31/2024; 0061797785 Exp. 03/31/2024; 0061797786 Exp. 03/31/2024; 0061797787 Exp. 03/31/2024; 0061797788 Exp. 03/31/2024; 0061809680 Exp. 04/30/2024
Recall details
- Recalling firm
- B. Braun Medical Inc., Daytona Beach, FL
- Quantity
- 483,229 bags
- Distribution
- USA Nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 10, 2023
Related products
- Sodium Chloride – drug information
- NDC 0264-5802 Sodium Chloride · Sodium Chloride .9 g/100mL · B. Braun Medical Inc.
- NDC 0264-5804 Sodium Chloride · Sodium Chloride .45 g/100mL · B. Braun Medical Inc.