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Anticoagulant Injection Recalled

August 21, 2020

Subpotency concerns have prompted SCA Pharmaceuticals to voluntarily recall more than 3900 bags of heparin sodium. According to August 19, 2020, US Food and Drug Administration (FDA) Enforcement Report, 30-day stability testing produced out-of-specification potency results. 

The recall affects heparin sodium, 5000 units in 0.9% sodium chloride 1000-mL bag (5 units/mL; NDC 70004-0650-46), from lots 1220018755 (Exp. 7/30/20); 1220018861 and 1220018850 (Exp. 8/4/20); 1220018899 (Exp. 8/5/20); 1220019027 (Exp. 8/11/20); 1220019075 (Exp. 8/12/20); 1220019243 (Exp. 8/20/20); 1220019439, 1220019279, and 1220019392 (Exp. 8/24/20); and 1220019488 (Exp. 8/26/20). The product was distributed throughout the United States. 

SCA Pharmaceuticals initiated the recall July 29, 2020. On August 12, 2020, the FDA designated the recall Class II, communicating use of the product may cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm. 

Heparin sodium is a prescription anticoagulant used to decrease blood clotting.

Jolynn Tumolo

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