Magnesium Sulfate In Water
FDA Recall NDC 0409-5239
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
The FDA has identified 3 recorded enforcement report(s) associated with Magnesium Sulfate In Water (NDC 0409-5239). A significant event, classified as Class II, was initiated on Oct 03, 2018 by Hospira, Inc.. The reported reason for this action was: "Correct Labeled Product Mispack: confirmed report involving a single unit of properly labeled Heparin in 0.45% Sodium Chloride for Injection (NDC 0409-7651-03, Lot 87903FW) that was found inside a case of Magnesium Sulfate in Water for Injection."
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
Correct Labeled Product Mispack: confirmed report involving a single unit of properly labeled Heparin in 0.45% Sodium Chloride for Injection (NDC 0409-7651-03, Lot 87903FW) that was found inside a case of Magnesium Sulfate in Water for Injection.
Oct 03, 2018
Oct 17, 2018
94,752 bags
Recall Profile & Regulatory Data
Event ID
81126
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Termination Date
Oct 02, 2020
Product Description
Magnesium Sulfate in Water for Injection (0.325 mEq Mg++/mL) 40 mg/mL, 20 g Total, 500 mL Single-Dose Container bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-6729-03.
Batch or Lot Expiration Information
Lot# Lot: 87904FW, Exp. 1MAR2020
Affected Packages Involved in this Recall
0409-6730-11Product
0409-6730-13Product
0409-6730-50Product
0409-6730-60Product
0409-6729-41Product
0409-6729-23Product
0409-6729-21Product
0409-6729-03Product
0409-6729-31Product
0409-6729-09Product
0409-6729-11Product
0409-6729-24Product
0409-4121-01Product
0409-4121-50Product
0409-2050-01Product
0409-2050-20Product
0409-3164-01Product
0409-3164-12Product
0409-5239-01Product
0409-5239-60Product
Class I Terminated
Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which scans in as heparin sodium.
Jan 05, 2016
Feb 24, 2016
213,600 bags
Recall Profile & Regulatory Data
Event ID
72996
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 28, 2017
Product Description
Magnesium Sulfate in Water for Injection, (0.325 mEq Mg++/mL) 40 mg/mL, 2 g Total, 50 mL Single-Dose Container bag, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6729-24.
Batch or Lot Expiration Information
Lot# Lot: 53-113-JT, Exp 1NOV2016
Affected Packages Involved in this Recall
0409-6730-11Product
0409-6730-13Product
0409-6730-50Product
0409-6730-60Product
0409-6729-41Product
0409-6729-23Product
0409-6729-21Product
0409-6729-03Product
0409-6729-31Product
0409-6729-09Product
0409-6729-11Product
0409-6729-24Product
0409-4121-01Product
0409-4121-50Product
0409-2050-01Product
0409-2050-20Product
0409-3164-01Product
0409-3164-12Product
0409-5239-01Product
0409-5239-60Product
Class III Terminated
Superpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesium sulfate.
Apr 05, 2012
Jun 27, 2012
164,568 containers
Recall Profile & Regulatory Data
Event ID
62053
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Hospira, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Aug 08, 2013
Product Description
Magnesium Sulfate in Water for Injection, 40 mg/mL (0.325 mEq Mg++/mL), 2 g total, 50 mL Flexible Container, Rx only, Hospira, Inc., Lake Forest, IL 60045; NDC 0409-6729-24.
Batch or Lot Expiration Information
Lot# : 04510KL*, Exp 01OCT2012; *lot number may have 01 or 02 following it
Affected Packages Involved in this Recall
0409-6730-11Product
0409-6730-13Product
0409-6730-50Product
0409-6730-60Product
0409-6729-41Product
0409-6729-23Product
0409-6729-21Product
0409-6729-03Product
0409-6729-31Product
0409-6729-09Product
0409-6729-11Product
0409-6729-24Product
0409-4121-01Product
0409-4121-50Product
0409-2050-01Product
0409-2050-20Product
0409-3164-01Product
0409-3164-12Product
0409-5239-01Product
0409-5239-60Product
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.
