Recalls / Class I
Class ID-1540-2022
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
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
- Brand name
- Propofol
- Generic name
- Propofol
- Active ingredient
- Propofol
- Route
- Intravenous
- NDCs
- 0409-4699, 0409-6010
- FDA application
- ANDA077908
- Affected lot / code info
- Lot#: EA7470, Exp 6/1/2023
Why it was recalled
Presence of particulate matter
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 235 East 42nd Street, New York, New York 10017-5703
Distribution
- Quantity
- 5,390 vials
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2022-08-22
- FDA classified
- 2022-09-19
- Posted by FDA
- 2022-09-21
- Terminated
- 2025-06-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1540-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.