Drug product

norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5026-02

D-0438-2026

March 20, 2026

Class II

Product summary

Firm: Fagron Compounding Services
Event: Event 98636
Status: Ongoing
Classification: Class II
Quantity: 25,260 bags
Official record key: drug-enforcement:D-0438-2026

Official wording

Reason: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port

Code information: Lot: C274-000049934, Exp.: 4/23/2026; C274-000049963, Exp.:4/24/2026; C274-000050074, Exp.: 4/30/2026; C274-000050123, Exp.:5/1/2026; C274-000050296, Exp.: 5/9/2026; C274-000050420, Exp.: 5/16/2026; C274-000050774, Exp.:6/5/2026; C274-000050924, 6/7/2026; C274-000050961, Exp.: 6/11/2026; C274-000050991, Exp.: 6/12/2026; C274-000051139, Exp.:6/19/2026; C274-000051166, Exp.:6/20/2026; C274-000051198, Exp.:6/21/2026; C274-000051343, Exp.:6/28/2026.

Distribution pattern: Nationwide in the U.S.A.

Derived failure modes

Sterility assurance
reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility