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Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lak...

FDA Recall #D-0856-2021 — Class II — September 17, 2021

Recall #D-0856-2021 Date: September 17, 2021 Classification: Class II Status: Terminated

Product Description

Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-452-01. 25 vials per tray packaged 18 trays per shipper

Reason for Recall

Defective container: Cracked vials leading to lack of sterility assurance

Recalling Firm

Fresenius Kabi USA LLC — Melrose Park, IL

Classification

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

Product Type

Drugs

Product Quantity

963000 vials

Distribution

U.S.A. Nationwide

Code Information

Lot # 6023731, 6023732, Exp 03/2023; 6024172, 6024260, Exp 06/2023

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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