Compounded Heparin Sodium Recalled

SCA Pharmaceuticals (Windsor, CT) announced on August 18, 2020 that it is voluntarily recalling 10 lots of heparin sodium because the product contains undeclared benzyl alcohol, a preservative. Methylparaben and propylparaben, which are not contained in the product, were listed on the label as preservatives. The labeling problem was identified when the company was investigating a low potency test result.

Heparin Sodium is used as an anticoagulant, and the company stated in a press release that “serious adverse reactions including fatal reactions and ‘gasping syndrome’ are likely to occur in premature neonates and low-birth weight infants in the neonatal intensive care unit who receive benzyl alcohol as a preservative in infusion solutions, in any amount.” Because of these and other possible adverse reactions, the company stated that preservative-free heparin sodium injections are recommended for pregnant patients and “Benzyl alcohol is contraindicated in pediatric patients as well as pregnant or nursing women.”

As of the time of the press release, the company has not received any reports of adverse events. Information on the recalled lots can be found on FDA.gov and adverse events may be reported to FDA’s MedWatch program.