FDA Recall D-0862-2017

Hospira Inc. · Lake Forest, IL

Class I — life-threatening Ongoing 3310 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

Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Single-dose Syringe per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1775-10

Lot / code: Lot 58382EV*, Exp 1OCT 2017, *lot may be followed by 01 or 02

Quantity: 71,550 syringes

Reason for recall

Presence of Particulate Matter: human hair found within an internal sample syringe.

Recall record

Recall number: D-0862-2017
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Nationwide in the USA and Puerto Rico
Recall initiated: 2017-04-21
Classified by FDA Center: 2017-05-24
FDA published: 2017-05-31
Recalling firm: Hospira Inc.
Firm location: Lake Forest, IL

Drug identification

Brand name(s): DEXTROSE
Generic name(s): DEXTROSE MONOHYDRATE
Manufacturer(s): Hospira, Inc.
NDC(s): 0409-1775
Route(s): INTRAVENOUS

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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