Recalls / Class II
Class IID-0431-2024
Product
Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00
- Brand name
- Lactated Ringers
- Generic name
- Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride
- Active ingredients
- Calcium Chloride, Potassium Chloride, Sodium Chloride, Sodium Lactate
- Route
- Intravenous
- NDC
- 0264-7750
- FDA application
- NDA019632
- Affected lot / code info
- Lot #: J3N023, Exp: 31 March 2026
Why it was recalled
Lack of assurance of sterility: bags have the potential to leak..
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
- 7,800 bags
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-03-22
- FDA classified
- 2024-04-03
- Posted by FDA
- 2024-04-10
- Terminated
- 2025-07-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0431-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.