American Regent Recalls Calcium Gluconate Injection

A voluntary nationwide recall was just initiated, at the consumer and user level, for lot 1006 of Calcium Gluconate Injection, USP, the U.S. Food and Drug Administration (FDA) just announced. The recalled Calcium Gluconate Injection was distributed to wholesalers and distributors nationwide.

Some vials in lot 1006 of the defective Calcium Gluconate Injection may contain silicone particles. Following intravenous administration of solutions containing particulates, disruption of blood flow within small blood vessels in the lung, granuloma formation, and localized inflammation–swelling and redness because of an accumulation of inflammatory cells—can occur.

Calcium Gluconate is used to treat conditions resulting from calcium deficiencies such as hypocalcemic tetany, hypocalcemia related to hypoparathyroidism, and hypocalcemia due to rapid growth or pregnancy. The drug can be used to treat black widow spider bites to relieve muscle cramping and as part of the treatment for rickets, osteomalacia, lead colic, and magnesium sulfate overdose. Calcium Gluconate is also used reduce the permeability in capillaries in allergic conditions; nonthrombocytopenic purpura and exudative dermatoses, such as dermatitis herpetiformis; and for drug-induced pruritus of eruptions. In hyperkalemia, Calcium Gluconate may by used to assist in antagonizing the cardiac toxicity in patients not undergoing digitalis therapy.

Calcium Gluconate Injection, USP, 10%, is a supersaturated solution 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 when uses. As stated in the Package Insert: “Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.”

Hospitals, infusion centers, clinics, and other healthcare facilities should not use American Regent Inc., Calcium Gluconate Injection, USP, 10%, Lot # 1006 for patient care, and should immediately quarantine any product for return to American Regent, Inc.

American Regent will credit accounts for all returned products with lot number 1006. American Regent’s Customer Service Department can be reached, toll-free, at 1.877.788.3232 Monday through Friday, from 8:30 a.m. to 7:00 p.m., Eastern Daylight Time (EDT).

Any adverse reactions experienced with the use of this product should be reported to American Regent, Inc. via e-mail at pv@luitpold.com; by fax to 1.610.650.0170; or by phone at 1.800.734.9236, Monday through Friday from 9:00 a.m. to 5:00 p.m., EDT.

Adverse reactions or quality problems may be reported to the FDA’s MedWatch Adverse Event Reporting program: Online at www.fda.gov/medwatch/report.htm; by regular mail via the postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm, which is then to be mailed to the address on the pre-addressed form; or by fax to 1.800.FDA.0178.

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