Fresenius Kabi Compounding, Llc: Vancomycin Hcl, 1.5 Grams, 1.5 Grams Added To
Recall Summary Vancomycin HCl 1.5 grams in 500 mL saline solution manufactured by Fagron Sterile Services and distributed by Fresenius Kabi Compounding is being recalled nationwide because the company cannot confirm the product is sterile. This is a serious recall because the antibiotic is given intravenously to patients, and non-sterile injectable medication poses a significant risk of infection.
- Recalling firm
- Fresenius Kabi Compounding, LLC
- Product
- vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-016-59
- Reason
- Lack of Assurance of Sterility
- Classification
- Class I
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-02-05
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/86490333-3ae8-4338-9afd-89e6f9a4c9ef