American Regent has initiated a voluntary nationwide recall of a batch of calcium gluconate injections due to the presence of silicone particulates.
The recall affects lot number 1,006 of calcium gluconate injection, USP, 10%, 100mL.
American Regent has distributed the injections, manufactured by Luitpold Pharmaceuticals, to wholesalers and distributors nationwide.
Calcium gluconate is indicated to treat conditions such as hypocalcaemic tetany or hypocalcaemia, to relieve muscle cramping due to black widow spider bites, rickets, osteomalacia, lead colic and magnesium sulphate overdoses.
The injection has also been employed to decrease capillary permeability in allergic conditions, non-thrombocytopenic purpura and exudative dermatoses such as dermatitis herpetiformis and for pruritus of eruptions caused by certain drugs.
In hyperkalaemia, calcium gluconate may aid in antagonising the cardiac toxicity provided the patient is not receiving digitalis therapy.