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Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose Fliptop Vial...

FDA Recall #D-0184-2023 — Class I — December 22, 2022

Recall #D-0184-2023 Date: December 22, 2022 Classification: Class I Status: Terminated

Product Description

Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose Fliptop Vial, 10 vials per carton, Rx only, Distributed by: Hospira, Inc., Lake Forest, IL 60045. NDC Vial 0409-3515-11; NDC Carton 0409-3515-01

Reason for Recall

Presence of Particulate Matter: Glass particulate matter detected in injectable.

Recalling Firm

Pfizer Inc. — New York, NY

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

89,700 vials

Distribution

USA nationwide and Puerto Rico

Code Information

Lot: 33045BA, EXP 1SEP2023

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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