Recalls / Class I
Class ID-0628-2025
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, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, 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 #: V3K770, Exp 1/31/2026
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
- 861 Marcon Blvd, N/A, Allentown, Pennsylvania 18109-9577
Distribution
- Quantity
- 47,148 containers
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2025-08-18
- FDA classified
- 2025-09-10
- Posted by FDA
- 2025-09-10
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0628-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.