Calcium Gluconate Injection Under Voluntary Recall

Calcium Gluconate Injection Under Voluntary RecallA nationwide voluntary recall was issued on July 18 for Calcium Gluconate Injection, USP, 10 percent. The recall only pertains to lot 1006, the 100 mL pharmacy bulk package expiring January 2013. Other sizes or lots of Calcium Gluconate Injection, USP, are not a part of the recall.

Hospitals and any other facilities with this product on hand should not use the injection for patient care and should send all products back to American Regent, a distributor of Luitpold Pharmaceuticals. All returned products will result in a credit on the corresponding accounts.

The product, distributed by American Regent, was recalled because silicone particles were found in some of the vials. After intravenous injection, these particles may disrupt blood flow in some blood vessels, particularly in the lung, and could result in swelling or redness due to an accumulation of cells. Granuloma formation, an area of tissue inflammation, could also be a side effect of exposure to this contamination.

When functioning properly, calcium gluconate treats hypocalcemic tetany, hypocalcemia and hypoparathyroidism. These conditions may be the result of calcium deficiencies, rapid growth or pregnancy. The medication can also help relieve muscle cramps that result from black widow spider bites, and treat rickets, osteomalacia or magnesium sulfate overdoses.

Other issues involving the calcium gluconate injection include precipitation in all lots and sizes of the drug, according to the American Society of Health-System Pharmacists. The 10 percent concentration of calcium salt causes the medication to be a supersaturation. These precipitates will dissolve when the vials of calcium gluconate are warmed, but facilities should still be conscious of this potential issue.

Any adverse reactions to calcium gluconate should be reported to American Regent, Luitpold Pharmaceuticals and MedWatch, the program run by the FDA that handles safety information.