Why it was recalled
Presence of Particulate Matter
Product description
0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-09.
Lot numbers, UPCs & expiration codes
Lot #: J2L763, J2L764, Exp: 31 March 2025
Where it was sold
Nationwide within U.S.A
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-0638-2024
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Jul 24, 2024
- FDA report date
- Aug 28, 2024
- Quantity
- 63,444 containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- B. Braun Medical Inc
Original FDA data
Every field from FDA enforcement report D-0638-2024, exactly as published.
Show all FDA fields
- City
- Irvine
- State
- CA
- Status
- Ongoing
- Country
- United States
- Event ID
- 95035
- Address
- 2525 Mcgaw Ave
- Code information
- Lot #: J2L763, J2L764, Exp: 31 March 2025
- Postal code
- 92614-5841
- Report date
- Aug 28, 2024
- Product type
- Drugs
- Recall number
- D-0638-2024
- Classification
- Class I
- Recalling firm
- B. Braun Medical Inc
- Product quantity
- 63,444 containers
- Reason for recall
- Presence of Particulate Matter
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-09.
- Distribution pattern
- Nationwide within U.S.A
- Recall initiation date
- Jul 24, 2024
- Initial firm notification
- Letter
- Center classification date
- Aug 19, 2024