Class III · Low risk Ongoing
Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceutical ingredient (API), Avantor Performance…
Reason Subpotent drug
EPSOM SALT(Magnesium Sulfate Heptahydrate, USP), 50 lb multi-wall bag, Rx only…
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)).
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.
- Recalling firm
- PQ Corporation
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0564-2016
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Magnesium recalls
See all
Class I · High risk Ongoing
Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags, Rx…
Reason 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 Ongoing
INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato…
Reason Failed Disintegration Specifications: above the time expected.
Class II · Moderate risk Ongoing
Magnesium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Glutathione Magnesium for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL…
Reason Lack of Assurance of Sterility
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