Recall of Heparin Sodium Compounded Products By SCA Pharmaceuticals
The National Agency for Food and Drug Administration and Control has received information from the US FDA about the voluntary recall of Ten (10) lots of heparin sodium products by SCA pharmaceutical. The recall is due to presence of incorrect preservative (Benzyl Alcohol). Whereas the labelling of the products listed methyl paraben and propyl paraben as preservatives, the compounded heparin sodium bag contains the undeclared preservative benzyl alcohol. Methyl paraben and propyl paraben are not present in the product.
SCA pharmaceutical identified this labelling issue during the investigation of a low potency test result for Heparin Sodium (NDC 70004-0650-46).
Heparin Sodium is used as an anticoagulant and is packaged in 500 mL or 1000 mL intravenous bags.
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 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. Preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol.
Also, 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 are recommended when heparin therapy is needed during pregnancy. Benzyl alcohol is contraindicated in pediatric patients as well as pregnant or nursing women.
The details of the affected Heparin Sodium Compounded Products manufactured by SCA pharmaceuticals are as follows:
|Product Description||NDC Number||Lot Number||Beyond Use Date|
|Heparin Sodium 10 units/mL in 0.9% Sodium Chloride 500 mL Bag (5,000 units/500 mL)||70004-0650-44||1220019289||8/21/2020|
|Heparin Sodium 5 units/mL in 0.9% Sodium Chloride 500 mL Bag (2,500 units/500 mL)||70004-0655-44||1220019269||8/21/2020|
|Heparin Sodium 10 units/mL in 0.9% Sodium Chloride 1,000 mL Bag (10,000 units/1,000 mL)||70004-0652-46||1220019457||8/24/2020|
|Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000mL Bag (5 units/mL)||70004-0650-46||1220019243||8/20/2020|
- Healthcare professionals and Hospitals that have compounded Heparin Sodium bags which are being recalled should stop using the product and return it to their distributors or submit the product to the nearest NAFDAC office.
- 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.
Healthcare professionals are encouraged to report any adverse events or side effects related to the use of this product to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or email@example.com