CLASS III Drug recall · Reported 26 Jul 2017 · FDA Enforcement Report
Argatroban Injection, 250 mg/ (100 mg/mL) Single-use vial recalled
Hospira Inc., A Pfizer is recalling Argatroban Injection, 250 mg/ (100 mg/mL) Single-use vial, distributed nationwide in the US. The recall was initiated on 6 Jul 2017 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0980-2017
- FDA event ID
- 77687
- Recalling firm
- Hospira Inc., A Pfizer, Lake Forest, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 6 Jul 2017
- FDA classified
- 14 Jul 2017
- Reported
- 26 Jul 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 6 Jul 2017 | Recall initiated by company | |
| 14 Jul 2017 | Classified by FDA | +8 days |
| 26 Jul 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma Limited, Hyderabad, India, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 --- NDC 0409-1140-01
Where it was distributed
Nationwide
Questions about this recall
Is Argatroban Injection, 250 mg/ (100 mg/mL) Single-use vial recalled?
Yes. Hospira Inc., A Pfizer recalled Argatroban Injection, 250 mg/ (100 mg/mL) Single-use vial on 6 Jul 2017. The recall is Class III and its status is Terminated. Recall number D-0980-2017.
Why was it recalled?
Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
Which lots are affected?
Lot: DP601, exp 10/2018
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Hospira Inc., A Pfizer
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Labetalol Hydrochloride Injection, USP, 100 mg recalledLabetalol Hydrochloride | Hospira Inc. A Pfizer | Foreign Material | Nationwide |
| Drug | CLASS II | Levophed norepinephrine bitartrate, injection, USP, 4 mg / (1 mg/mL) recalledLevophed | Hospira Inc., A Pfizer | Packaging Defects | Nationwide |
| Drug | CLASS I | Vancomycin Hydrochloride for Injection, USP, Pharmacy recalled | Hospira Inc., A Pfizer | Particulate Matter | Nationwide |
| Drug | CLASS II | METRONIDazole Injection, USP 500 mg (5 mg/mL) recalled | Hospira Inc., A Pfizer | Sterility | Nationwide |
| Drug | CLASS I | Bupivacaine Hydrochloride Inj., USP 5 mg/mL) recalledBupivacaine Hydrochloride | Hospira Inc., A Pfizer | Particulate Matter | Nationwide |
Other Argatroban recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Argatroban Injection, 250 mg/ (100 mg/mL) Single-use Vial recalled | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | Argatroban Injection in 9% Sodium Chloride 250 mg/ (1 mg/mL) recalled | Teva North America | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Argatroban Injection 50 mg recalled by Eagle Pharmaceuticals | Eagle Pharmaceuticals | Particulate Matter | NJ |