Hospira, Inc. has issued a voluntary nationwide recall of one lot of Vancomycin Hydrochloride Injection, USP 1.5g/vial, due to the presence of visible glass particulates observed in multiple vials from one batch. The user level recall affects lot 33045BA, distributed nationwide to wholesalers, distributors, and hospitals throughout the United States and Puerto Rico between June 23, 2022, and September 19, 2022.
Risk Statement
Intravenous administration of glass particulates could potentially lead to local irritation, phlebitis, granuloma formation, or inflammation. In addition, embolization of the glass may occur, which can result in material plugging blood vessels and leading to pulmonary emboli (blood clots). Oral or nasogastric tube administration can also pose a risk of gastrointestinal trauma.
Healthcare professionals can reduce the risk by possible detection. The label contains a statement directing recipients to inspect each vial upon receipt before use. If any particulate is observed, the vial should not be used, and Pfizer should be contacted.
The recall is being initiated due to the presence of visible glass particulates, which could potentially lead to adverse events. Hospira, Inc. has not received any reports of injury or illness associated with this product recall and is recalling out of an abundance of caution.
Indications
Vancomycin Hydrochloride Injection, USP 1.5g/vial, is indicated in the treatment of infections caused by susceptible strains of Gram-positive microorganisms, including methicillin-resistant Staphylococcus aureus (MRSA). The antibiotic effectively treats staphylococcal endocarditis, bone infections, and other serious infections caused by resistant strains of Gram-positive bacteria.
Patients with penicillin allergy and those who cannot receive or have failed to respond to antimicrobials such as cephalosporins, aminoglycosides, and other agents are candidates for vancomycin therapy.
Detailed information about the affected products is indicated in the table below:
| Product | NDC | Lot
Number |
Expiration
Date |
Presentation | Configuration/
Count |
| Vancomycin Injection,
USP, Single- Dose Fliptop Vial |
Vial: 0409-3515-11 Carton: 0409-3515-01 |
33045BA | 1SEP2023 | 1.5 g/Vial | 10
units/carton, 10 cartons/case |
What To Do
Pfizer is notifying direct consignees by press release and recall letter with details of this recall.
Wholesalers, distributors, and institutions with an inventory of the affected products should discontinue the distribution and use and quarantine the products immediately. If you’ve further distributed the products, inform your customers about the recall and arrange for the return.
Customers who have the product should stop using it immediately and contact Sedgwick Inc. at 1-800-805-3093 between 8:00 a.m. to 5:30 p.m. Eastern Standard Time, Monday through Friday, for instructions on how to return the product.
Consumers should contact their healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Healthcare providers and institutions with questions regarding the recall can contact Pfizer using the details indicated in the table:
| Contact Center | Contact Information | Area of Support |
| Pfizer Medical Information | 1-800-438-1985,
option 3 (9 am to 5 pm ET Monday through Friday) |
For medical questions regarding the product |
| Pfizer Drug Safety | 1-800-438-1985, option 1
(24 hours a day; 7 days a week) |
To report adverse events and product complaints |
Adverse events may also be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Report Online https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home
- Regular Mail: Use postage-paid FDA form 3500 available at: https://www.fda.gov/MedWatch/getforms.htm
- Fax: 1-800-FDA-0178
This recall is conducted with full knowledge of the U.S. Food and Drug Administration.
