Amidate — Class III drug recall D-0054-2016
Ongoing recall by Hospira Inc., reported 2015-10-28, distributed nationwide. Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation product of eto
| Recall number | D-0054-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2015-09-29 |
| Classified | 2015-10-21 |
| Reported by FDA | 2015-10-28 |
| Distributed | Nationwide (US) |
| Quantity | 24,100 syringes |
| Reason classes | specification failure |
| NDC | 00409-8060-29 |
| Lot numbers | 34-531-DK |
| Expiration dates | 2015-10-01 |
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
Reason for recall
Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation product of etomidate was confirmed during stability testing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0054-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.