MedWatch Warns of Particulates in Argatroban Injections

Less than a year after approval and before the product could really get off the ground, the FDA has issued a MedWatch notice on a recall of The Medicines Company’s anticoagulant Argatroban injection because of visible particulates. An investigation revealed a particulate in a stability sample of distributed product, the FDA said March 23. After re-inspecting undistributed products, investigators found several vials with small numbers of particulates.
Drug GMP Report