Hospira Inc. recalls Amidate (Etomidate Injection, USP), 40 mg/20 mL (2 mg/mL), LifeShield, 20 mL, Glass Abboject Syringe with male luer loc…

Recall date

September 29, 2015

Source

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

Recall number

D-0054-2016

FDA classification

Class III

Brand / firm

Hospira Inc.

Sold / distributed

Nationwide

Why it was recalled

Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation product of etomidate was confirmed during stability testing.

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

What was recalled

Amidate (Etomidate Injection, USP), 40 mg/20 mL (2 mg/mL), LifeShield, 20 mL, Glass Abboject Syringe with male luer lock adapter, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-8060-29