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Recall Observatory FDA recall evidence

Drug product

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

D-0054-2016

September 29, 2015

Class III

Product summary

Firm
Hospira Inc.
Event
Event 72432
Status
Ongoing
Classification
Class III
Quantity
24,100 Syringes
Official record key
drug-enforcement:D-0054-2016

Official wording

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

Code information: Lot 34-531-DK, Exp 10/01/2015

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out of Specification