Drug product
Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5085-01
D-0441-2026
Product summary
- Event
- Event 98636
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 16,130 bags
- Official record key
drug-enforcement:D-0441-2026
Official wording
Reason: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Code information: Lot: C274-000050858, Exp.:7/6/2026; C274-000051018, Exp.: 7/13/2026; C274-000049194, Exp.: 4/20/2026; C274-000049591, Exp.: 5/9/2026; C274-000049592, Exp.: 5/9/2026; C274-000049823, Exp.: 5/18/2026; C274-000050301, Exp.: 6/8/2026; C274-000050411, Exp.: 6/13/2026; C274-000051056, Exp.:7/18/2026.
Distribution pattern: Nationwide in the U.S.A.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility