openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
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drug · product 1 of 1
Argatroban Injection 50 mg per 50ml (1 mg per ml) For Intravenous Infusion Only, a) Single Use Vial (NDC 42367-203-07), b) 10 Single Use Vials(NDC 42367-203-84), Rx Only, Manufactured by: Cipla LTD, India, Manufactured for: Eagle Pharmaceuticals, Inc. Woodcliff Lake, NJ 07677 USA, Marketed by: The Medicines Company, Parsippany, NJ 07054 USA
Foreign material or chemical contaminationreason.foreign_material_chemical_contamination · v1.0.0
particulates
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a single vial from Lot V10194. Additional small visible particles consisting of fibers were identified.
Code information
Lot #V10189, Lot #V10191, Lot #V10194, Exp 01/13; Lot #V10223; Exp 02/13
