5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC., Lake F...

FDA Recall #D-0265-2022 — Class II — November 30, 2021

Recall #D-0265-2022 Date: November 30, 2021 Classification: Class II Status: Terminated

Product Description

5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC., Lake Forest, IL 60045 USA, NDC 0409-7100-68/0409-7100-66

Reason for Recall

Lack of sterility assurance: bag has the potential to leak.

Recalling Firm

Pfizer Inc. — New York, NY

Classification

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

Product Type

Drugs

Product Quantity

765 bags

Distribution

USA Nationwide

Code Information

Lot: 4923608 Exp. 1MAY2022

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated