Pfizer Inc. recalls Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira, In
Recalled September 19, 2018 · FDA recall D-1184-2018 · Pfizer
Hazard
Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point · FDA Class III
Units
1,580 vials
Sold at
Nationwide USA
Description
Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
Product
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
Manufacturer(s)
Pfizer Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →