Drug 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.
D-0337-2026
Product summary
- Event
- Event 98391
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0337-2026
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot # C274-000047611, Exp Date: 10-Feb-26; Lot # C274-000049633, Exp Date: 12-May-26.
Distribution pattern: US Nationwide.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility