Hospira, Inc., a Pfizer company is issuing a voluntary nationwide recall of one lot of Propofol Injectable Emulsion, USP (Containing Benzyl Alcohol). The affected product is a 100 mL Single Patient Use Glass Fliptop Vial, Lot DX9067.
The user-level recall is being conducted due to the potential for the presence of visible particulate matter in a single vial. The presence of visible particulate was discovered during the annual examination of the retained samples.
Risk Statement
Propofol is used as an induction and maintenance agent for general anesthesia, as well as a sedative and hypnotic for procedural sedation. Propofol is also used to treat status epilepticus.
Propofol is supplied in 20 mL single-dose vials, each containing 1 g of propofol in an oily vehicle (20% Intralipid). The product is for single use only and any unused portion should be discarded.
The presence of visible particulate is associated with life-threatening risks including the potential for local irritation and inflammation upon injection. It could cause blockage of blood vessels resulting in decreased blood flow to the brain, pulmonary embolus, heart attack, and tissue necrosis. There is also the potential for hypersensitivity reactions and transmission of infectious diseases.
Hospira Inc. has not received any reports of adverse events related to this issue to date.
This particular lot of Propofol Injectable Emulsion, USP (Containing Benzyl Alcohol), 100 mL Single Patient Use Glass Fliptop Vial, Lot DX9067 were distributed between June 10, 2020, to June 26, 2020, to wholesalers/distributors and hospitals in the United States. Further details of the recalled products are indicated in the table below.
| Product | NDC | Lot Number | Expiration DatePresentation | Configuration/Count |
| Propofol Injectable Emulsion, USP 100 mL Single Patient Use Glass Fliptop Vial | Vial: 0409-4699-54 Carton: 0409-4699-24 |
DX9067 | 01 MAY 2023 | 1 g/100 mL, Single Patient Use Glass Fliptop Vial
Case of 10 Units |
Actions Taken
Hospira Inc. is notifying its customers by letter and is arranging for the return of all affected product lots. Wholesalers or distributors that still have the products are urged to stop the further distribution of the lots indicated in the table and quarantine any remaining inventory.
They should notify any accounts or hospitals that may have received the affected lots and arrange for the return of any remaining product. Hospitals and healthcare institutions are also urged to inform their staff of this recall and to stop using any of the affected products.
Customers with questions regarding this recall can contact Sedgwick Inc. at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.
Healthcare professionals with medical questions regarding the product can reach out to Pfizer for medical information through 1-800-438-1985, option 3 (8 am to 9 pm ET Monday through Friday) or www.pfizermedinfo.com.
To make a report on the adverse effects and complaints, healthcare professionals should contact Pfizer Drug Safety at 1-800-438-1985, option 1 (24 hours a day; 7 days a week).
Adverse reactions and quality issues can be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Online: www.fda.gov/medwatch/report.htm
- Regular Mail: use the mailing address found at www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return the form to the address on the pre-addressed form.
- Fax: 1-800-FDA-0178
Patients should always consult their healthcare professional for medical advice. This is especially important if the patient has a known medical condition or is taking other medications.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
