Magnesium Chloride
Subpotent drug
Class I — High risk. Reasonable probability of serious harm or death.
Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect barcode on the immediate container that scans as heparin sodium 2000 USP units/1000 mL in 0.9% in sodium chloride injection.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION, USP, 10 mg/mL; 100 mL bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6727-23, UPC (01) 0 030409 672723 1.
Compare with the code on your package — it is the most precise check available.
Drug: Magnesium
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Magnesium Sulfate in Dextrose NDC 00409-6727 |
MAGNESIUM SULFATE HEPTAHYDRATE 10 mg/mL | Injection, Solution Intravenous |
Hospira, Inc. | Rx |
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Subpotent drug
Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.
Failed Disintegration Specifications: above the time expected.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Presence of Particulate Matter: human hair found within an internal sample syringe.
Lack of Assurance of Sterility: Complaints of broken tips on the ampules.
Discoloration: Firm received complaints of product discoloration and particulates.
Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.
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