Fresenius Kabi Compounding, Llc: Vancomycin Hcl, 2 Grams, 2 Grams Added To
Recall Summary Fresenius Kabi Compounding, LLC is recalling vancomycin HCl 2-gram injections mixed with saline solution (NDC 71506-019-59) distributed nationwide because the company cannot guarantee the product is sterile. This is a Class I recall, meaning there is a reasonable possibility the product could cause serious adverse health effects or death.
- Recalling firm
- Fresenius Kabi Compounding, LLC
- Product
- vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-019-59.
- 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/1da24a82-9e28-473b-baec-b7d9d0b45a4e