December 22, 2016
Cantrell Drug Company is recalling 1494 syringes of Heparin Sodium, 1 USP Unit/2 mL (0.5 USP Units/mL) in 0.45% Sodium Chloride.
The US Food and Drug Administration (FDA) Enforcement Report for the week of December 21 lists the reason for the voluntary recall as “lack of assurance of sterility - the firm is recalling select sterile drug products.”
Managing Overprescription of Oral Anticoagulants
Non-Major Bleeding Tied to Higher Risk of Death, Major Bleeding in AF
Single-dose syringes from Lot 9220 are included in the ongoing, Class II recall. The affected syringes were distributed nationwide.
The recall was initiated on November 18, and the FDA classified the recall as Class II on December 13. The FDA describes a Class II recall as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”--Meredith Edwards White
Enforcement Report. US Food and Drug Administration Website. http://www.accessdata.fda.gov/scripts/ires/index.cfm. Published December 21, 2016. Accessed December 21, 2016.