FDA-Drug2017-07-26Class III
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
Hospira Inc., A Pfizer Company
Hazard
Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
Sold states
Nationwide
Affected count
701 vials
Manufactured in
275 N Field Dr, N/A, Lake Forest, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0980-2017Don't want to check this manually?
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