Reported Sep 19, 2018 · Terminated
Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira,…
Pfizer Inc.
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: Pfizer Inc. · 235 E 42nd St · New York, NY · 10017-5703
Is this the product you have?
- Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile
- Manufactured forHospira, Inc, Lake Forest, IL 60045 USA
- NDC0409-1140-01
- Lot codes and dates
- Lot
DP60210/2018
- Lot
- Amount recalled
- 1,580 vials
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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