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Recall Observatory FDA recall evidence

Drug product

Norepinephrine Bitartrate Injection 16 mg per 250 mL added to 0.9% Sodium Chloride, 16 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-476-15

D-0707-2022

March 14, 2022

Class II

Product summary

Firm
Athenex Pharma Solutions, LLC
Event
Event 89779
Status
Terminated
Classification
Class II
Quantity
5,320 bags
Official record key
drug-enforcement:D-0707-2022

Official wording

Reason: Defective container

Code information: Lot #: F2101634, Exp 3/30/22; F2101665, F2101666, Exp 4/02/22; F2101788, F2101789, Exp 4/26/22; F2101811, F2101812, F2101815, Exp 4/29/22

Distribution pattern: USA nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Defective container