FDA-Drug2026-10-26Class IPROCESSING DEFECT
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.
Hazard
Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the United States
Affected count
18,991 vials
Manufactured in
870 Parkdale Rd, Rochester, Michigan, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0082-2027Also reported as
More Paragon 28 recalls
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.