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Recall Observatory FDA recall evidence

Drug product

Phenylephrine HCl Injection 50 mg per 250 mL in 0.9% Sodium Chloride, 50 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-494-15

D-0710-2022

March 14, 2022

Class II

Product summary

Firm
Athenex Pharma Solutions, LLC
Event
Event 89779
Status
Terminated
Classification
Class II
Quantity
1,800 bags
Official record key
drug-enforcement:D-0710-2022

Official wording

Reason: Defective container

Code information: Lot #: F2101652, F2101653, Exp 5/30/22; F2200111, Exp 7/27/22

Distribution pattern: USA nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Defective container