Recalls / Class III
Class IIID-0054-2016
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
- Affected lot / code info
- Lot 34-531-DK, Exp 10/01/2015
Why it was recalled
Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation product of etomidate was confirmed during stability testing.
Recalling firm
- Firm
- Hospira Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 24,100 Syringes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-09-29
- FDA classified
- 2015-10-21
- Posted by FDA
- 2015-10-28
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0054-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.