Recalls / Class I
Class ID-0638-2024
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-09.
- Brand name
- Sodium Chloride
- Generic name
- Sodium Chloride
- Active ingredient
- Sodium Chloride
- Route
- Intravenous
- NDC
- 0264-7800
- FDA application
- NDA019635
- Affected lot / code info
- Lot #: J2L763, J2L764, Exp: 31 March 2025
Why it was recalled
Presence of Particulate Matter
Recalling firm
- Firm
- B. Braun Medical Inc
- Manufacturer
- B. Braun Medical Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2525 Mcgaw Ave, Irvine, California 92614-5841
Distribution
- Quantity
- 63,444 containers
- Distribution pattern
- Nationwide within U.S.A
Timeline
- Recall initiated
- 2024-07-24
- FDA classified
- 2024-08-19
- Posted by FDA
- 2024-08-28
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0638-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.