Par Health Usa, Llc: Argatroban Injection, Usp, 250 Mg/2

Par Pharmaceutical is recalling Argatroban Injection (a blood thinner medication) because the vials may contain small particles of cellulose, plastic, metal, or stopper material in the solution. The recall affects the 250 mg/2.5mL vials distributed nationwide across all U.S. states. This medication is prescription-only and used in hospitals and clinical settings.

Recalling firm
Par Health USA, LLC
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/ Distributed by: Par Pharmaceutical, Cranbury, NJ 08512, NDC 42023-182-89.
Reason
Particulate matter: potential for the presence of particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-10-13
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
Nationwide within the United States

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/1bf4e473-1782-40f6-b82e-a45fc439c928