September 03, 2020
A Class I recall has been issued for 10 lots of SCA Pharmaceuticals’ heparin sodium packaged in 500-mL or 1000-mL intravenous bags. According to the September 2, 2020, US Food and Drug Administration (FDA) Enforcement Report, the product contains the undeclared preservative benzyl alcohol. Also, the preservatives methylparaben and propylparaben are listed on the label but are not present in the product.
A Class I recall designation warns that use of the product could cause serious adverse health consequences or death.
“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,” SCA Pharmaceuticals stated in an August 18, 2020, announcement. “Additional adverse reactions include gradual nervous system deterioration, seizures, bleeding in the skull, blood abnormalities, skin breakdown, liver and kidney failure, low blood pressure, slower than expected heart rate, and loss of sufficient brain blood flow to maintain consciousness.”
Benzyl alcohol is also contraindicated in pediatric patients as well as pregnant or nursing women, the company explained.
The recall includes the following products, which were distributed to hospitals throughout the United States:
- heparin sodium 10 units/mL in 0.9% sodium chloride, 500-mL bags (5000 units/500 mL, NDC 70004-0650-44) from lot 1220019289 (Exp. 8/21/20);
- heparin sodium 5 units/mL in 0.9% sodium chloride, 500-mL bags (2500 units/500 mL, NDC 70004-0655-44) from lots 1220019269 (Exp. 8/21/20), 1220019278 (Exp. 8/21/20), and 1220019386 (Exp. 8/25/20);
- heparin sodium 10 units/mL in 0.9% sodium chloride, 1000-mL bags (10,000 units/1000 mL, NDC 70004-0652-46) from lot 1220019457 (Exp. 8/24/20); and
- heparin sodium 5000 units in 0.9% sodium chloride, 1000-mL bags (5 units/mL, NDC 70004-0650-46) from lots 1220019243 (Exp 8/20/20), 1220019439 (Exp. 8/24/20), 1220019279 (Exp. 8/24/20), 1220019392 (Exp. 8/24/20), and 1220019488 (Exp. 8/26/20).
SCA Pharmaceuticals initiated the voluntary recall July 29, 2020. On August 27, 2020, the FDA issued its Class I designation.
Heparin sodium is a prescription anticoagulant.