FDA Recall D-0865-2016

Hospira Inc. · Lake Forest, IL

Class I — life-threatening Ongoing 3709 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, Hospira Inc, Lake Forest, IL 60045, NDC 0409-6625-02

Lot / code: Lot # 56-148-EV, Exp 8/1/2017

Quantity: 72,000 units

Reason for recall

Presence of Particulate Matter: particulate matter identified as an insect in one vial.

Recall record

Recall number: D-0865-2016
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide
Recall initiated: 2016-03-18
Classified by FDA Center: 2016-05-23
FDA published: 2016-06-01
Recalling firm: Hospira Inc.
Firm location: Lake Forest, IL

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

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

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