Drug product
Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5082-01
D-0442-2026
Product summary
- Event
- Event 98636
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 11,680 bags
- Official record key
drug-enforcement:D-0442-2026
Official wording
Reason: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Code information: Lot: C274-000050987, Exp.:7/12/2026; C274-000049425, Exp.: 5/2/2026; C274-000050069, Exp.: 5/30/2026; C274-000050346, Exp.: 6/10/2026; C274-000050698, Exp.: 6/27/2026; C274-000050699, Exp.:6/27/2026; C274-000050775, Exp.:7/4/2026.
Distribution pattern: Nationwide in the U.S.A.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility