CLASS III Drug recall · Reported 19 Sep 2018 · FDA Enforcement Report
Argatroban Injection, 250 mg/ (100 mg/mL) Single-use Vial recalled
Pfizer is recalling Argatroban Injection, 250 mg/ (100 mg/mL) Single-use Vial, distributed nationwide in the US. The recall was initiated on 28 Aug 2018 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-1184-2018
- FDA event ID
- 80923
- Recalling firm
- Pfizer, New York, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 28 Aug 2018
- FDA classified
- 7 Sep 2018
- Reported
- 19 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 28 Aug 2018 | Recall initiated by company | |
| 7 Sep 2018 | Classified by FDA | +10 days |
| 19 Sep 2018 | 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 stability testing results at the 18 month time point
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 USA. NDC: 0409-1140-01
Where it was distributed
Nationwide USA
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
Which lots are affected?
Lot: DP602, 10/2018
Where was it sold?
Nationwide USA
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 26 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 Pfizer
All 127| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dopamine HCl Inj., USP, 200 mg/ (40 mg/mL) Single-dose recalledDopamine Hydrochloride | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq recalledSodium Bicarbonate | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | Vial Label: Epinephrine Injection, USP, 1mg/ (0.1 mg/mL) recalled | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | Levoxyl (levothyroxine sodium tablets, USP), 50 mcg recalled by PfizerLevoxyl | Pfizer | Potency & Assay | NY |
| Drug | CLASS II | Bicillin L-A (penicillin G benzathine injectable recalled by PfizerBicillin L-a | Pfizer | Particulate Matter | Nationwide |
Other Argatroban recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Argatroban Injection, 250 mg/ (100 mg/mL) Single-use vial recalled | Hospira Inc. A Pfizer | Potency & Assay | Nationwide |
| Drug | CLASS II | Argatroban Injection in 0.9% Sodium Chloride 250 mg/ (1 mg/mL) recalled | Teva North America | Manufacturing (CGMP) Deviations | Nationwide |