Hospira sent a letter on Monday to tell healthcare professionals about crystallization in some lots of the chemotherapy drug Cytarabine. The specialty drugmaker determined the crystals are particles of the API.
Hospira, which has corrected the problem, says a root cause analysis indicates dried Cytarabine on filling needles as the most likely cause. Particles may enter the vials during production and then seed crystal formation.
Cytarabine, both powder for reconstitution and the solution form, is among drugs in short supply, according to the FDA. Shortages are currently listed by the three makers of the drug: Hospira, Bedford Labs and APP Pharmaceuticals. API shortage and manufacturing delays are listed as causes.