Home » MedWatch Warns of Particulates in Argatroban Injections
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
Drug GMP Report
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