FDA Recall D-1301-2022
Pfizer Inc. · New York, NY
Class I — life-threatening Terminated 670 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-1301-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- USA Nationwide
- Recall initiated
- 2022-07-13
- Classified by FDA Center
- 2022-08-03
- FDA published
- 2022-08-03
- Terminated
- 2024-05-13
- Recalling firm
- Pfizer Inc.
- Firm location
- New York, NY
Drug identification
- Brand name(s)
- PROPOFOL
- Generic name(s)
- PROPOFOL
- Manufacturer(s)
- Hospira, Inc.
- NDC(s)
0409-4699, 0409-6010- Route(s)
- INTRAVENOUS