Why it was recalled
Presence of particulate matter: particulate identified as a beetle.
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
Lot numbers, UPCs & expiration codes
Lot #: DX9067, Exp 5/1/2023
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1301-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jul 13, 2022
- FDA report date
- Aug 3, 2022
- Quantity
- 54,000 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-1301-2022, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 90581
- Address
- 235 East 42nd Street
- Code information
- Lot #: DX9067, Exp 5/1/2023
- Postal code
- 10017-5703
- Report date
- Aug 3, 2022
- Product type
- Drugs
- Recall number
- D-1301-2022
- Classification
- Class I
- Recalling firm
- Pfizer Inc.
- Product quantity
- 54,000 vials
- Termination date
- May 13, 2024
- Reason for recall
- Presence of particulate matter: particulate identified as a beetle.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Jul 13, 2022
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Aug 3, 2022