Par Health and Endo USA Argatroban Injection 250 mg/2.5 mL (100 mg/mL)
Argatroban Injection contains particulate matter that can cause life-threatening blood vessel blockages and inflammation.
2 photos
What happened
Par Health is voluntarily recalling Argatroban Injection 250 mg/2.5 mL (100 mg/mL) nationwide due to the presence of particulate matter identified as cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel. The recall covers 22 lots distributed to wholesalers and hospitals between December 30, 2024, and May 5, 2026.
Administration of the product containing particulate matter can cause life-threatening adverse health consequences including pulmonary emboli, occlusions of other blood vessels, and inflammation of the walls of veins.
Par Health has not received any reports of adverse events related to this recall. The company is providing written notification to wholesale and hospital accounts and arranging for return of existing inventory through Inmar, Inc.
Summary by Recall Canary from the FDA notice.
What to do
If a code on your package matches:
- Par Health is providing written notification to wholesale and hospital accounts that have received the affected lots and is arranging for return of all existing inventory through Inmar, Inc. Wholesale distributors and hospital pharmacies that have the product being recalled should immediately discontinue use and stop distribution.
- If you have further distributed the recalled product, please notify your accounts or any additional locations which may have received the recalled product.
- Questions regarding this recall can be directed to Inmar, Inc. at 1-855-648-7909 Monday through Friday between the hours of 9 a.m. and 5 p.m. ET or by email at rxrecalls@
inmar.com. - For medical or technical product information or to report a product complaint or adverse event please call 1-800-828-9393 Monday through Thursday between the hours of 9 a.m. and 8 p.m. ET or Friday between 9 a.m. and 6 p.m. ET.
Is yours affected?
Match your product and all the details in one listed combination.
Argatroban Injection 250 mg/2.5 mL (100 mg/mL), Distributed by: Par Pharmaceutical* or Endo USA*
- NDC
- 42023-182-01
- Lot code
- 83449
- Best-by
- 10/2026
- NDC
- 42023-182-01
- Lot code
- 82682
- Best-by
- 11/2026
- NDC
- 42023-182-01
- Lot code
- 86714
- Best-by
- 02/2027
- NDC
- 42023-182-01
- Lot code
- 87302
- Best-by
- 02/2027
- NDC
- 42023-182-01
- Lot code
- 87560
- Best-by
- 02/2027
- NDC
- 42023-182-01
- Lot code
- 87753
- Best-by
- 03/2027
- NDC
- 42023-182-01
- Lot code
- 88401
- Best-by
- 03/2027
- NDC
- 42023-182-01
- Lot code
- 88614
- Best-by
- 04/2027
- NDC
- 42023-182-01
- Lot code
- 88836
- Best-by
- 04/2027
- NDC
- 42023-182-01
- Lot code
- 90220
- Best-by
- 05/2027
- NDC
- 42023-182-01
- Lot code
- 91216
- Best-by
- 06/2027
- NDC
- 42023-182-01
- Lot code
- 91219
- Best-by
- 06/2027
- NDC
- 42023-182-01
- Lot code
- 92004
- Best-by
- 07/2027
- NDC
- 42023-182-01
- Lot code
- 92006
- Best-by
- 07/2027
- NDC
- 42023-182-01
- Lot code
- 92009
- Best-by
- 08/2027
- NDC
- 42023-182-01
- Lot code
- 92596
- Best-by
- 08/2027
- NDC
- 42023-182-01
- Lot code
- 92782
- Best-by
- 08/2027
- NDC
- 42023-182-01
- Lot code
- 93107
- Best-by
- 08/2027
- NDC
- 42023-182-01
- Lot code
- 93329
- Best-by
- 08/2027
- NDC
- 42023-182-01
- Lot code
- 93890
- Best-by
- 09/2027
- NDC
- 42023-182-89
- Lot code
- 84193
- Best-by
- 10/2026
- NDC
- 42023-182-89
- Lot code
- 92880
- Best-by
- 08/2027
Details
- Company announced
- Sold in
These lots were distributed nationwide to wholesalers and hospitals between December 30, 2024, and May 5, 2026.
- Company
- Par Health
- Hazard
- Foreign material
