FDAFDA · Food and drugs·Recall number D-0980-2017
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
Published July 26, 2017 · Recall initiated: July 6, 2017
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 result for denitroquinoline-related impurity during three month time point
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hospira Inc., A Pfizer Company
- Distributor
- Nationwide
- Lot
- Lot: DP601, exp 10/2018
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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