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

FDA recall notice · announced August 3, 2022 · Pfizer

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

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.

Notes

Distribution: USA Nationwide
Lot/code information: Lot #: DX9067, Exp 5/1/2023
Quantity: 54,000 vials
Status: Terminated
Products in this recall event:
- 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, Distribute (D-1301-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.