FDA-Drug2026-04-15Class IIPROCESSING DEFECT

Fagron norepinephrine injection recalled for sterility concerns and port defect

Nationwide distribution

Stop using Fagron norepinephrine injection

Fagron Compounding Services is recalling norepinephrine bitartrate injection due to two issues: the sterility of the product cannot be assured, and a blue plastic part on the administration port may detach during use. This medication is used in hospitals and medical facilities to treat critical conditions. Six specific lots distributed nationwide are affected.

  • If you work in a hospital or medical facility, check if you have any of the affected lots (C274-000050004, C274-000050295, C274-000050773, C274-000051219, C274-000051318, or C274-000051602)
  • Do not use any affected bags; remove them from stock immediately
  • Contact Fagron Compounding Services or your supplier for instructions on return or disposal
  • Notify your pharmacy or medical director if you have already used any affected doses
Hazard

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

Sold states
Nationwide in the U.S.A.
Affected count
5140 bags
Manufactured in
8710 E 34th St N, Wichita, KS, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0439-2026

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