Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-1944-20
Reported: March 20, 2024 Initiated: March 6, 2024 #D-0370-2024
Product Description
Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-1944-20
Reason for Recall
Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.
Details
- Recalling Firm
- B. Braun Medical Inc
- Units Affected
- 22,752 bags
- Distribution
- Nationwide in the USA
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-1944-20. Recalled by B. Braun Medical Inc. Units affected: 22,752 bags.
Why was this product recalled? ▼
Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 20, 2024. Severity: Moderate. Recall number: D-0370-2024.
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