Milrinone Lactate Injection, Solution
FDA Recall NDC 72485-503
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 (NDC 72485-503). A significant event, classified as Class III, was initiated on Aug 14, 2023 by Armas Pharmaceuticals Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications"
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
August 2023 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Terminated
Failed Impurities/Degradation Specifications
Aug 14, 2023
Sep 13, 2023
19, 820 vials
Recall Profile & Regulatory Data
Event ID
92900
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Caplin Steriles Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in Tennessee
Termination Date
Sep 09, 2025
Product Description
Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL), packaged in 10 x 20 mL vials per carton, NDC 72485-502-01 (single vial), Rx only, Distributed by: Armas Pharmaceuticals, Inc. Freehold, NJ 07728(USA) Manufactured by: Caplin Steriles Limited, India, NDC 72485-502-10
Batch or Lot Expiration Information
Lot# : 90000228
Affected Packages Involved in this Recall
72485-501-01Product
72485-501-10Product
72485-502-01Product
72485-502-10Product
72485-503-01Product
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.
