FDA-Drug2018-09-19Class III
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
Pfizer Inc.
Hazard
Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
Sold states
Nationwide USA
Affected count
1,580 vials
Manufactured in
235 E 42nd St, N/A, New York, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1184-2018Don't want to check this manually?
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