Class III · Low risk
Magnesium Chloride
Subpotent drug
MAGNESIUM Sulfate 4 g added to 100 mL 0.9% Sodium Chloride
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
MAGNESIUM Sulfate 4 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0737-32.
Affected NDC
70004-0737-32
Compare with the code on your package — it is the most precise check available.
Drug: Magnesium
- Recalling firm
- SCA Pharmaceuticals
- Origin
- AR, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1003-2017 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Magnesium recalls
See all
Class I · High risk
Magnesium Sulfate in Water for Injection
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.
Class II · Moderate risk
INON ACE Antacid tablets
Failed Disintegration Specifications: above the time expected.
Class II · Moderate risk
Magnesium Chloride for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Glutathione Magnesium for Injection
Lack of Assurance of Sterility
Other recalls by SCA Pharmaceuticals
All 2017 recalls
Class II · Moderate risk
VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection
Lack of Assurance of Sterility
Class II · Moderate risk
SUCcinylcholine Chloride 100 mg/5mL Injection
Lack of Assurance of Sterility
Class II · Moderate risk
SUCcinylcholine Chloride 200 mg/10mL Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Sodium Citrate 4% 3 mL
Lack of Assurance of Sterility
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