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Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE F...

FDA Recall #D-309-2013 — Class II — August 28, 2012

Recall #D-309-2013 Date: August 28, 2012 Classification: Class II Status: Terminated

Product Description

Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12

Reason for Recall

Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.

Recalling Firm

Hospira Inc. — Lake Forest, IL

Classification

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

Product Type

Drugs

Product Quantity

172,350 vials

Distribution

Nationwide and Puerto Rico

Code Information

Lot 17-100-EV and 17-399-EV

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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