Par Health Recalls Argatroban Injection Vials Due to Particulate Matter
Par Health USA, LLC is recalling 1,944 vials of Argatroban Injection due to the presence of particulate matter in the solution.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I due to the presence of particulate matter (cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material) in an intravenous injection. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Par Health USA, LLC is voluntarily recalling 1,944 vials of Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL). The product is a prescription-only intravenous medication distributed nationwide within the United States. The recall involves single-dose vials with NDC 42023-182-89, manufactured for Endo USA and distributed by Par Pharmaceutical.
The recall was initiated because particulate matter was identified in the product solution. The source text specifies that the particulate matter was identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material. The affected lots are 84193 with an expiration date of 10/2026 and 92880 with an expiration date of 08/2027.
Healthcare providers and patients should discontinue use of the affected vials and contact their pharmacist or the recalling firm for further instructions. The source text does not report any illnesses, injuries, or deaths associated with this recall.
The recalled product
- Product
- ARGATROBAN (ARGATROBAN)
- Brand
- ARGATROBAN
- Manufacturer
- Par Health USA, LLC
- Category
- Drug — Prescription Drug
- Affected units
- 1,944
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: 84193
- Exp Date: 10/2026
- 92880
- Exp Date: 08/2027.
Distribution
Distributed nationwide across the United States.
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