Lmd In Sodium Chloride Injection, Solution
FDA Recall NDC 0409-7419
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 Lmd In Sodium Chloride (NDC 0409-7419). A significant event, classified as Class II, was initiated on Oct 02, 2019 by Hospira, Inc.. The reported reason for this action was: "Lack of Assurance of Sterility: Bag has the potential to leak."
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: Bag has the potential to leak.
Oct 02, 2019
Oct 16, 2019
17832 bags
Recall Profile & Regulatory Data
Event ID
83947
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the United States and Puerto Rico
Termination Date
Dec 01, 2020
Product Description
10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection, USP, 500 mL bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7418-13
Batch or Lot Expiration Information
Lot# : 87-095-JT Exp. 1MAR2020
Affected Packages Involved in this Recall
0409-7418-13Product
0409-7418-03Product
0409-7419-14Product
0409-7419-03Product
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.
