Eagle Pharmaceuticals Inc., supplier to The Medicines Company, issued a recall of all four lots of Argatroban Injection, 50 mg per 50 mL from the market due to a potential for visible particulates. The risk of using an injectable product with particulates includes embolization/infarction to organs and potential organ complications.
During an investigation, a visible particulate was discovered in a stability sample in one of the distributed lots. This discovery prompted a re-inspection of undistributed lots at the manufacturing site. Upon this re-inspection, a small number of visible particulates were discovered in several vials. The affected products include: NDC# 42367-203-07 (single unit), NDC# 42367-203-84 (10 pack).
See the FDA Recall