Recalls / Class I
Class ID-1211-2015
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
Lactated Ringers Injection, USP, 250mL VIAFELX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0117-02
- Brand name
- Lactated Ringers
- Generic name
- Sodium Chloride, Potassium Chloride, Sodium Lactate And Calcium Chloride
- Active ingredients
- Calcium Chloride, Potassium Chloride, Sodium Chloride, Sodium Lactate
- Route
- Intravenous
- NDC
- 0338-0117
- FDA application
- NDA016682
- Affected lot / code info
- Lot #: C964619, C964056 and C964163, Exp 7/31/2016
Why it was recalled
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Recalling firm
- Firm
- Baxter Healthcare Corp.
- Manufacturer
- Baxter Healthcare Company
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, N/A, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 58,932 bags
- Distribution pattern
- US, Puerto Rico, and Bermuda
Timeline
- Recall initiated
- 2015-03-24
- FDA classified
- 2015-07-06
- Posted by FDA
- 2015-07-15
- Terminated
- 2017-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1211-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.