PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass fliptop vial (NDC 0...

FDA Recall #D-1540-2022 — Class I — August 22, 2022

Recall #D-1540-2022 Date: August 22, 2022 Classification: Class I Status: Terminated

Product Description

PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass fliptop vial (NDC 0409-4699-54) further packaged in a tray of 10 vials (NDC Carton: 0409-4699-24), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

Reason for Recall

Presence of particulate matter

Recalling Firm

Pfizer Inc. — New York, NY

Classification

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

Product Type

Drugs

Product Quantity

5,390 vials

Distribution

USA Nationwide

Code Information

Lot#: EA7470, Exp 6/1/2023

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated