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Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per glass fliptop vial (N...

FDA Recall #D-1301-2022 — Class I — July 13, 2022

Recall #D-1301-2022 Date: July 13, 2022 Classification: Class I Status: Terminated

Product Description

Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per 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: particulate identified as a beetle.

Recalling Firm

Pfizer Inc. — New York, NY

Classification

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

Product Type

Drugs

Product Quantity

54,000 vials

Distribution

USA Nationwide

Code Information

Lot #: DX9067, Exp 5/1/2023

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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