COMPANY ANNOUNCEMENT
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company’s announcement as a public service. FDA does not endorse either the product or the company.
Summary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
- Reason for Announcement:
-
Recall Reason Description
Particulate matter (cardboard) found in the solution.
- Company Name:
- Baxter International Inc.
- Brand Name:
-
Brand Name(s)
Baxter
- Product Description:
-
Product Description
Cefazolin in Dextrose Injection
Company Announcement
Risk Statement: The use of the defective product has a reasonable probability of causing pulmonary emboli (blockage in pulmonary blood vessels), occlusions of other blood vessels (which can lead to tissue death and possible organ damage), and/or phlebitis (inflammation of the walls of veins, which may lead to clotting). Systemically, foreign particles infused intravenously can cause systemic activation of the immune system, organ dysfunction, and hemolysis (breakdown of blood cells). To date, Baxter has not received any reports of adverse events related to this issue.
Affected Product:
This product is used intravenously to treat bacterial infections or prevent them during surgery
| Product Code | Product Description | Lot Number | Expiration Date | NDC Number |
|---|---|---|---|---|
| 2G3508 | Cefazolin in Dextrose Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in 100mL GALAXY Plastic Container, Frozen Premix | LD175708 | 14-Feb-2027 | 0338-3508-41 |
Company Contact Information
- Consumers:
- (888) 229-0001
- Media:
- Brenna Byrne
- (224) 948-5353
- media@baxter.com
Product Photos
