0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10.
Reported: July 2, 2025 Initiated: June 16, 2025 #D-0491-2025
Product Description
0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10.
Reason for Recall
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Details
- Recalling Firm
- B BRAUN MEDICAL INC
- Units Affected
- 187,656 containers
- Distribution
- USA Nationwide
- Location
- Allentown, PA
Frequently Asked Questions
What product was recalled? ▼
0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10.. Recalled by B BRAUN MEDICAL INC. Units affected: 187,656 containers.
Why was this product recalled? ▼
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 2, 2025. Severity: Moderate. Recall number: D-0491-2025.
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