Compounded Heparin Sodium Recall Issued Due To Lack Of Preservatives, Infant Death Risk
Federal health officials are warning about problems with compounded heparin products, which may contain preservatives that could seriously injure or kill infants and newborns.
The FDA announced a Heparin Sodium recall on August 18, after the manufacturer found certain lots of the medication contain benzyl alcohol, which if given to pregnant or nursing mothers could cause potentially life threatening injuries to infants.
Heparin sodium is a prescription anticoagulant used to prevent blood clots from forming or growing in the blood vessels. The treatment is often used to treat certain blood vessel, heart, and lung conditions, as well as during medical procedures such as open-heart surgery, bypass surgery, kidney dialysis, and blood transfusions.
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FDA officials indicate that, during routine testing, the products were found to contain low potency test results for the listed preservatives methylparaben and propylparaben.
The test results also determined certain lots of the medication contained the undeclared preservative benzyl alcohol, which may cause serious and fatal adverse reactions if introduced to infants either directly or through mothers nursing newborns.
According to the FDA, any amount of benzyl alcohol introduced to premature neonates and low-birth weight infants could cause an increased risk of serious injury or death due to their inability to metabolize the solution.
Officials warn potential side effects could 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.
The recall includes ten lots of Heparin Sodium packaged in 500 mL or 1000 mL intravenous bags. The products were manufactured by SCA Pharmaceuticals (SCA) of Windsor, Connecticut, and were sold and distributed to hospitals nationwide.
The FDA and manufacturer instruct customers to stop using the recalled lots of heparin sodium immediately and to quarantine the products. SCA has begun notifying customers by certified mail with instructions on how to arrange a return of all recalled lots.
Customers with additional questions are encouraged to contact SCA at 877-550-5059 or email them at email@example.com.
The FDA is encouraging all patients and healthcare providers to report any adverse events related to the product to the MedWatch Adverse Event Reporting program.
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