PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: August 3, 2022 Initiated: July 13, 2022 #D-1301-2022

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.

Details

Recalling Firm
Pfizer Inc.
Units Affected
54,000 vials
Distribution
USA Nationwide
Location
New York, NY

Frequently Asked Questions

What product was recalled?
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. Recalled by Pfizer Inc.. Units affected: 54,000 vials.
Why was this product recalled?
Presence of particulate matter: particulate identified as a beetle.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 3, 2022. Severity: Critical. Recall number: D-1301-2022.