FDA Recall D-0054-2016

Hospira Inc. · Lake Forest, IL

Class III Ongoing 3880 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

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

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

Quantity: 24,100 Syringes

Reason for recall

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

Recall record

Recall number: D-0054-2016
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide
Recall initiated: 2015-09-29
Classified by FDA Center: 2015-10-21
FDA published: 2015-10-28
Recalling firm: Hospira Inc.
Firm location: Lake Forest, IL

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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