D-1540-2022 Class I Terminated

Recalled by Pfizer Inc. — New York, NY

FDA drug recall D-1540-2022 was initiated by Pfizer Inc. on August 22, 2022 and is designated Class I. Reason for recall: Presence of particulate matter The recall status is terminated (terminated June 30, 2025). Affected quantity: 5,390 vials.

Recall Details

Product Type
Drugs
Report Date
September 21, 2022
Initiation Date
August 22, 2022
Termination Date
June 30, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,390 vials

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

Distribution Pattern

USA Nationwide

Code Information

Lot#: EA7470, Exp 6/1/2023