Infumorph 200 Injection, Solution
FDA Recall NDC 0641-6039
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 Infumorph 200 (NDC 0641-6039). A significant event, classified as Class II, was initiated on Mar 12, 2024 by Hikma Pharmaceuticals Usa Inc.. The reported reason for this action was: "The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
March 2024 Class II Recall: The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
Recall Number
Class II Ongoing
The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
Mar 12, 2024
Mar 27, 2024
22,644 ampuls
Recall Profile & Regulatory Data
Event ID
94208
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Hikma Pharmaceuticals USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC 0641-6039-01
Batch or Lot Expiration Information
Lot# : 052001, 052003, Exp. Date 11/2024; 023012, 023014, Exp. Date 08/2024
Affected Packages Involved in this Recall
0641-6039-01Product
0641-6040-01Product
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.
