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, I…

Recall date

August 28, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1184-2018

FDA classification

Class III

Brand / firm

Pfizer Inc.

Sold / distributed

Nationwide USA

Why it was recalled

Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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