Drug product
norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5027-02
D-0439-2026
Product summary
- Event
- Event 98636
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5140 bags
- Official record key
drug-enforcement:D-0439-2026
Official wording
Reason: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Code information: Lot: C274-000050004, Exp.: 4/24/2026; C274-000050295, Exp.:5/8/2026; C274-000050773, Exp.: 6/4/2026; C274-000051219, Exp.: 6/21/2026; C274-000051318, Exp.: 6/27/2026; C274-000051602, Exp.: 7/12/2026.
Distribution pattern: Nationwide in the U.S.A.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility