Blood Thinner Recalled

Advanced Pharma Inc. is recalling nearly 2000 heparin syringes because of a lack of assurance of the product’s sterility, according to the March 27, 2019, US Food and Drug Administration (FDA) Enforcement Report. 

The recall affects the following heparin products, which were distributed throughout the United States:

• heparin 10 units/10 ml 10 units in 0.45% sodium chloride, qs 10 ml, injectable solution, dwell, 10-ml sterile single-use syringes (NDC 42852-725-61), from lot 10/23/18 1998 72561SPF (Exp. 3/22/19); and
• heparin 5000 units/5 ml (1000 units per ml) injectable solution, 5000 units in 0.9% sodium chloride, qs 5-ml sterile single-use syringes  (NDC 42852-739-67), from lot 10/25/18 4819 73967S (Exp. 3/24/19).

Advanced Pharma Inc. voluntarily initiated the recalls March 13, 2019. On March 21, 2019, the FDA designated them Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Heparin is an anticoagulant that helps prevents blood clots.

—Jolynn Tumolo