Blood Thinner Recalled

Pfizer Inc. is recalling 1580 vials of argatroban injection, 250 mg/2.5 mL (100 mg/mL), according to the September 19, 2018, US Food and Drug Administration (FDA) Enforcement Report.

The recall, prompted by out-of-specification results during stability testing at 18 months, affects  2.5-mL single-use vials (NDC 0409-1140-01) from lot DP602 (Exp. 10/18). Vials from the lot were shipped across the United States.

Pfizer voluntarily initiated the recall August 28, 2018. The FDA designated it Class III September 7, 2018. The classification communicates that use of the recalled vials is unlikely to lead to adverse health consequences.

Argatroban injection is a prescription anticoagulant indicated for prophylaxis or treatment of thrombosis in adults with heparin-induced thrombocytopenia. It is also used as an anticoagulant in adults undergoing percutaneous coronary intervention at risk of experiencing heparin-induced thrombocytopenia.

—Jolynn Tumolo

For more Pharmacy Learning Network articles, visit the homepage

To learn about Pharmacy Learning Network Live meetings, click here