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Recall Observatory FDA recall evidence

Drug product

Norepinephrine Bitartrate16 mg added to 0.9% Sodium Chloride 250 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025014801

D-0028-2018

October 10, 2017

Class II

Product summary

Firm
Banner Pharmacy Services, LLC
Event
Event 78227
Status
Terminated
Classification
Class II
Quantity
481 bags
Official record key
drug-enforcement:D-0028-2018

Official wording

Reason: Lack of Assurance of Sterility.

Code information: Lot #: 072717S4, Exp 10/26/2017; 080917S2, Exp 11/8/2017; 082517S1, Exp 11/24/2017

Distribution pattern: Nationwide within the US

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility