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Recall Observatory FDA recall evidence

Drug product

Norepinephrine Bitartrate Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-475-15

D-0708-2022

March 14, 2022

Class II

Product summary

Firm
Athenex Pharma Solutions, LLC
Event
Event 89779
Status
Terminated
Classification
Class II
Quantity
9,800 bags
Official record key
drug-enforcement:D-0708-2022

Official wording

Reason: Defective container

Code information: Lot #: F2101639, F2101642, F2101644, F2101645, Exp 4/30/22; F2101674, F2101675, F2101676, Exp 5/05/22; F2101790, F2101791, F2101792, F2101793, F2101794, Exp 5/26/22; F2101813, Exp 5/29/22

Distribution pattern: USA nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Defective container