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ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL Vials, Rx o...

FDA Recall #D-0296-2015 — Class II — September 27, 2012

Recall #D-0296-2015 Date: September 27, 2012 Classification: Class II Status: Terminated

Product Description

ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-373-02

Reason for Recall

Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.

Recalling Firm

Fresenius Kabi USA, LLC — Lake Zurich, IL

Classification

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

Product Type

Drugs

Product Quantity

184,550 Vials

Distribution

U.S. Nationwide Including Puerto Rico

Code Information

Lot 6003930, exp. date 04/2014

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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