Recalls / Class II
Class IID-0370-2024
Product
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
- Brand name
- Potassium Chloride
- Generic name
- Potassium Chloride
- Active ingredient
- Potassium Chloride
- Route
- Parenteral
- NDC
- 0264-1944
- FDA application
- ANDA085870
- Affected lot / code info
- Lot #: J2S007, Exp: 12/31/2024; J3A115, Exp: 01/31/2025.
Why it was 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.
Recalling firm
- Firm
- B. Braun Medical Inc
- Manufacturer
- B. Braun Medical Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2525 Mcgaw Ave, N/A, Irvine, California 92614-5841
Distribution
- Quantity
- 22,752 bags
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-03-06
- FDA classified
- 2024-03-08
- Posted by FDA
- 2024-03-20
- Terminated
- 2025-04-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0370-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.