FDA-Drug2015-10-28Class III

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

Hospira Inc.
Hazard

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

Sold states
Nationwide
Affected count
24,100 Syringes
Manufactured in
275 N Field Dr, N/A, Lake Forest, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0054-2016

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