Calcium Gluconate Injection Recalled Because of Silicone Particles

One lot of Calcium Gluconate Injection, USP, 10%, 100 mL Pharmacy Bulk Package, has been recalled by American Regent because the vials may contain silicone particles, the company reported in a statement posted to FDA's Web site. The lot is #1006, Expiration Date: January 2013, NDC # 0517-3900-25. No other lots or sizes are involved.

Product users are instructed to inspect vials. The package insert states that: “Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.”

According to the statement, "Calcium Gluconate Injection, USP, 10% is a supersaturated solution and is prone to precipitation. Other lots and sizes may contain a precipitate that should dissolve upon warming. The Product Package Insert contains directions on dissolving this precipitate should it occur. However, the injection must be clear at the time of use."

"Potential adverse events after intravenous administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lung, localized inflammation (swelling and redness due to accumulation of inflammatory cells), and granuloma formation. American Regent is undertaking this voluntary recall in consideration of the potential for safety issues if this lot of product is administered to patients," the statement reads.

American Reagent reports that calcium gluconate "is used to treat conditions arising from calcium deficiencies such as hypocalcemic tetany, hypocalcemia related to hypoparathyroidism and hypocalcemia due to rapid growth or pregnancy. It is also used in the treatment of black widow spider bites to relieve muscle cramping and as an adjunct in the treatment of rickets, osteomalacia, lead colic and magnesium sulfate overdosage." More uses are listed in the statement.