FDAJuly 6, 2017drug

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point

What to do

FDA enforcement status: Terminated

Brands named

hospira inc a pfizerhospirahospira inc

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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