Par Health USA, LLC — Class I: Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only,
Par Health USA, LLC has initiated a Class I recall of Argatroban Injection, 250 mg/2.5mL, due to the presence of foreign particulate matter. The identified contaminants include cellulose, polystyrene, polyethylene terephthalate, stainless steel, and stopper material within the product solution.
This recall affects healthcare providers, distributors, and patients using Argatroban Injection (NDC 42023-182-01) manufactured for Endo USA and distributed by Par Pharmaceutical. It impacts manufacturing, quality control, and clinical staff involved in the administration of injectable anticoagulants.
A Class I designation indicates the highest level of urgency, where there is a reasonable probability that exposure to the product will cause serious adverse health consequences or death. The diversity of the particulates (plastics, metal, and stopper material) suggests a potential systemic failure in the manufacturing, filtration, or container-closure process, requiring a comprehensive root cause analysis and potentially significant CAPA implementation.
Quality units should conduct a thorough investigation into the source of multi-material contamination (polymers and metals) and review aseptic processing and container closure integrity. Immediate quarantine of the affected NDC and batch reconciliation is required. Clinical sites must be notified of the Class I status due to the high risk associated with injectable particulate matter.
Class I. Reason: Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.. Product: Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Manufactured for: Endo USA, Malvern,PA 19355/Argatroban Injection, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 42023-182-01.. Firm: Par Health USA, LLC (Rochester MI United States). Status: Ongoing.
Open in openFDA / FDA.gov