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Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira,...

FDA Recall #D-0153-2017 — Class II — November 1, 2016

Recall #D-0153-2017 Date: November 1, 2016 Classification: Class II Status: Terminated

Product Description

Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093-32

Reason for Recall

Lack of Assurance of Sterility: Complaints of broken tips on the ampules.

Recalling Firm

Hospira Inc. — Lake Forest, IL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

797,800 ampules

Distribution

Nationwide

Code Information

Lot #5 9277EV, 60028EV, 6008EV, Exp 11/1/17

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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