Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Gland Pharma Limited | Hyderabad, India | Makes it, makes the active ingredient, tests it and packages it | Problems found, fixed voluntarilyJul 25, 2024 · 7 inspections |
Recalls
- Aug 28, 2018 · Class III · Pfizer Inc.
Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
Lots: Lot: DP602, 10/2018 - Jul 6, 2017 · Class III · Hospira Inc., A Pfizer Company
Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
Lots: Lot: DP601, exp 10/2018
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Argatroban: every company that makes it
- Form
- injection, solution
- Strength
- 100 mg per 1 mL
- Approval
- ANDA ANDA204120
- On the market since
- Mar 6, 2017
- Package NDCs
0409-1140-01- Official label
- DailyMed (National Library of Medicine), updated Oct 10, 2022
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