Lactated Ringers Injection, Solution
FDA Recall NDC 0338-0117
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Lactated Ringers (NDC 0338-0117). A significant event, classified as Class I, was initiated on Mar 24, 2015 by Baxter Healthcare Company. The reported reason for this action was: "Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Terminated
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Mar 24, 2015
Jul 15, 2015
58,932 bags
Recall Profile & Regulatory Data
Event ID
70926
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US, Puerto Rico, and Bermuda
Termination Date
Feb 07, 2017
Product Description
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
Batch or Lot Expiration Information
Lot# : C964619, C964056 and C964163, Exp 7/31/2016
Affected Packages Involved in this Recall
0338-0117-02Product
0338-0117-03Product
0338-0117-04Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
