American Regent Drug Recall: Silicon Particles in Calcium Gluconate

One lot of calcium gluconate injections distributed by American Regent has been recalled due silicone particle contamination. 

The American Regent calcium gluconate recall was announced by the FDA on July 18, after some vials were found to contain particulate matter. The particles could disrupt blood flow in the small blood vessels of the lungs, cause inflammation and granuloma formation.

The recall notice did not explain how the silicon particles contaminated the vials, but indicated that there have been no reports of injuries from contaminated calcium gloconate injections.

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The recall affects lot #1006 of Calcim Gluconate Injection, USP, 10%, 100 mL. The affected vials have an expiration date of January 2013 and NDC # 0517-3900-25. No other lots are affected by the recall.

Calcium gluconate is used in the treatment black widow spider bites, as well as calcium deficiency caused by hypocalcemic tetany, hypocalcemia linked to hypoparathyroidism and hypocalcemia due to rapid growth or pregnancy. It is also used to treat rickets, osteomalacia, lead colic, magnesium sulfate overdose, some side effects of allergic conditions and conditions linked to hyperkalemia.

American Regent and the FDA are warning hospitals, clinics and other healthcare facilities not to use calcium gluconate injections affected by the recall. They have been instructed to immediately quarantine any affected supplies and return them to American Regent.

American Regent has said it will credit the accounts of facilities who return the potentially contaminated vials. Anyone with questions should call American Regent’s customer service department at 1-877-788-3232. Adverse reactions should be reported to American Regent and the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/medwatch/report.htm.

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