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.
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
Lot numbers, UPCs & expiration codes
Lot #: J2S007, Exp: 12/31/2024; J3A115, Exp: 01/31/2025.
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0370-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 6, 2024
- FDA report date
- Mar 20, 2024
- Quantity
- 22,752 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- B. Braun Medical Inc
Original FDA data
Every field from FDA enforcement report D-0370-2024, exactly as published.
Show all FDA fields
- City
- Irvine
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 94184
- Address
- 2525 Mcgaw Ave
- Code information
- Lot #: J2S007, Exp: 12/31/2024; J3A115, Exp: 01/31/2025.
- Postal code
- 92614-5841
- Report date
- Mar 20, 2024
- Product type
- Drugs
- Recall number
- D-0370-2024
- Classification
- Class II
- Recalling firm
- B. Braun Medical Inc
- Product quantity
- 22,752 bags
- Termination date
- Apr 16, 2025
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 6, 2024
- Initial firm notification
- Letter
- Center classification date
- Mar 8, 2024