Drug FDA Class II Terminated cGMP deviation
Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-014-58
Fresenius Kabi Compounding, LLC Published Oct 30, 2024
Risk level
Class IIMay cause a temporary or reversible health problem; slight chance of serious harm.
Severity score 55/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact Fresenius Kabi Compounding, LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall
cGMP violations
Affected products (1)
Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-014-58
1082 bags
Lot codes: C274-000038004
Code info: Lot # C274-000038004, exp. date 27-Nov-24
Affected areas
Nationwide
Timeline
- InitiatedSep 25, 2024
- PublishedOct 30, 2024
- TerminatedAug 15, 2025
- Recall number
- D-0018-2025
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.