Home / Recalls / Hospira Inc. / D-0054-2016

D-0054-2016 Class III Ongoing

Recalled by Hospira Inc. — Lake Forest, IL

FDA drug recall D-0054-2016 was initiated by Hospira Inc. on Sep 29, 2015 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation product of etomidate was confirmed during stability testing. The recall status is ongoing. Affected quantity: 24,100 Syringes.

Recall Details

Product Type: Drugs
Report Date: Oct 28, 2015
Initiation Date: Sep 29, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 24,100 Syringes

Product Description

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.

Distribution Pattern

Nationwide

Code Information

Lot 34-531-DK, Exp 10/01/2015

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0054-2016
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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