United States
Company name: SCA Pharmaceuticals
Brand name: SCA Pharma
Product recalled: Heparin Sodium Compounded products
Reason of the recall: Incorrect preservative (benzyl alcohol)
FDA Recall date: August 18, 2020
Recall details: Windsor, CT, SCA Pharmaceuticals (SCA) is voluntarily recalling 10 lots of Heparin Sodium to the hospital/user level. The compounded Heparin Sodium bag contains the undeclared preservative benzyl alcohol. The labelling listed methylparaben and propylparaben as preservatives; however, are not present in the product. SCA identified this labeling issue during the investigation of a low potency test result for Heparin Sodium (NDC 70004-0650-46).
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. Additional adverse reactions included 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.
Preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. Furthermore, benzyl alcohol present in mother’s serum is likely to cross into human milk and may be orally absorbed by a nursing infant. For this reason, preservative-free heparin sodium injections is recommended when heparin therapy is needed during pregnancy. Benzyl alcohol is contraindicated in pediatric patients as well as pregnant or nursing women.
SCA has not received any complaints or reports of adverse events to date related to this recall. However, out of an abundance of caution, SCA is voluntarily recalling the lots listed herein. Heparin Sodium is used as an anticoagulant and is packaged in 500 mL or 1000 mL intravenous bags. Check the link below to see the full list of affected Heparin Sodium lots.
The compounded Heparin Sodium can be identified by checking the product name, concentration and lot number on the compounded bag. The compounded Heparin Sodium bags were distributed nationwide to hospitals.
SCA is notifying its customers by certified mail and is arranging for return of all recalled products. Hospitals that have compounded Heparin Sodium bags which are being recalled should stop using the product and return the product to SCA.
Consumers with questions regarding this recall can contact SCA by phone at 877-550-5059 or e-mail customerservice@scapharma.com between the hours of 7:00 am and 7:00 pm (Central Standard Time), Monday through Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Check the full recall details on
www.fda.gov
Source: FDA
