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Recall Observatory FDA recall evidence

Drug product

NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-002-01.

D-0319-2022

November 12, 2021

Class II

Product summary

Firm
SterRx, LLC
Event
Event 89059
Status
Terminated
Classification
Class II
Quantity
1044 bags
Official record key
drug-enforcement:D-0319-2022

Official wording

Reason: Lack of Assurance of Sterility

Code information: S21194/CDW

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility