Status
Terminated
Drug Enforcement D-0370-2024
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.
Classification
Class II
Report Date
March 20, 2024
Termination Date
April 16, 2025
Product Information
- 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
- Product quantity
- 22,752 bags
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- B. Braun Medical Inc
- Address
-
2525 Mcgaw Ave, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0370-2024
- Event ID
- 94184
- Recall initiation date
- March 6, 2024
- Center classification date
- March 8, 2024
- Code info
- Lot #: J2S007, Exp: 12/31/2024; J3A115, Exp: 01/31/2025.
- More code info
- —