Class III · Low risk
Magnesium Chloride
Subpotent drug
Epsom Salt
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications: Level of iron exceeds the limit set by the USP monograph for it (USP limit is NMT 0.5 ug/g (ppm)).
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
EPSOM SALT(Magnesium Sulfate Heptahydrate, USP), 50 lb multi-wall bag, Rx only, Manufactured by PQ Corporation, P.O. Box 840, Valley Forge, Pennsylvania USA 19482.
Drug: Magnesium
- Recalling firm
- PQ Corporation
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0564-2016 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. 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 impurity / degradation recalls from 2015
All impurity / degradation recalls
Class III · Low risk
Candesartan Cilexetil Tablets
Failed Impurities/Degradation Specifications; 9 month stability timepoint
Class III · Low risk
Ranitidine Syrup
Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.
Class III · Low risk
Quinapril Tablets USP 5 mg
Failed Impurities/Degradation Specifications; Impurity A
Class III · Low risk
Meclizine Hydrochloride Tablets
Failed Impurities/Degradation Specifications: Out of specification for impurities.
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