Reported Jul 26, 2017 · Terminated
Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma…
Hospira Inc., A Pfizer Company
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hospira Inc., A Pfizer Company · 275 N Field Dr · Lake Forest, IL · 60045-2579
Is this the product you have?
- Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile
- Manufactured byGland Pharma Limited, Hyderabad, India
- Manufactured forHospira, Inc, Lake Forest, IL 60045 --- NDC 0409-1140-01
- Lot codes and dates
- Lot
DP601exp 10/2018
- Lot
- Amount recalled
- 701 vials
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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