Milrinone Lactate In Dextrose Injection, Solution
FDA Recall NDC 0338-6010
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 Milrinone Lactate In Dextrose (NDC 0338-6010). A significant event, classified as Class II, was initiated on May 15, 2017 by Baxter Healthcare Corporation. The reported reason for this action was: "Lack of assurance of sterility: customer complaints received for the presence of leaks."
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 II Terminated
Lack of assurance of sterility: customer complaints received for the presence of leaks.
May 15, 2017
May 24, 2017
90,450 bags
Recall Profile & Regulatory Data
Event ID
77247
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US and foreign countries: United Arab Emirates, Colombia, and Canada
Termination Date
Aug 10, 2018
Product Description
Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-6010-48
Batch or Lot Expiration Information
Lot# : P342485, Exp 11/30/17; P344408, Exp 12/31/17
Affected Packages Involved in this Recall
0338-6010-48Product
0338-6011-37Product
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.
