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
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
Out of Specification