FDAFDA · Food and drugs·Recall number D-1184-2018
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
Published September 19, 2018 · Recall initiated: August 28, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Pfizer Inc.
- Distributor
- Nationwide USA
- Lot
- Lot: DP602, 10/2018
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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