0.9% Sodium Chloride Injection USP recall
FDA recall D-0638-2024 · initiated Jul 24, 2024
B. Braun Medical Inc recalled 0.9% Sodium Chloride Injection USP in Jul 2024 — an FDA Class I recall (D-0638-2024) because Presence of Particulate Matter.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Presence of Particulate Matter
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 63,444 containers
Details
- Product
- 0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-09.
- Recalling company
- B Braun Medical
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within U.S.A
- Initiated
- Jul 24, 2024
- FDA report date
- Aug 28, 2024
Frequently asked
- Was 0.9% Sodium Chloride Injection USP recalled?
- B. Braun Medical Inc recalled 0.9% Sodium Chloride Injection USP in Jul 2024 — an FDA Class I recall (D-0638-2024) because Presence of Particulate Matter. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was 0.9% Sodium Chloride Injection USP recalled?
- Per the FDA enforcement record, the reason for recall D-0638-2024 was: Presence of Particulate Matter
- Is a recalled 0.9% Sodium Chloride Injection USP dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of 0.9% Sodium Chloride Injection USP are affected?
- Distributed: Nationwide within U.S.A. The recall covers these lots — Lot #: J2L763, J2L764, Exp: 31 March 2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0638-2024.