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Recall Observatory FDA recall evidence

Drug product

Norepinephrine Bitartrate 8 mg added to 0.9% Sodium Chloride 250 mL in a bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025011501

D-0022-2018

October 10, 2017

Class II

Product summary

Firm
Banner Pharmacy Services, LLC
Event
Event 78227
Status
Terminated
Classification
Class II
Quantity
3550 bags
Official record key
drug-enforcement:D-0022-2018

Official wording

Reason: Lack of Assurance of Sterility.

Code information: Lot #: 071217S2, Exp 10/11/2017; 071417S1, Exp 10/13/2017; 071917S2, 071917S3, Exp 10/18/2017; 072117S1, Exp 10/20/2017; 072617S2, 072617S3, Exp 10/25/2017; 072817S2, Exp 10/27/2017; 073117S2, 10/30/2017; 080217S2, Exp 11/1/2017; 080717S2, Exp 11/6/2017; 081117S2, Exp 11/10/2017; 081417S2, Exp 11/13/2017; 081617S2, Exp 11/15/2017; 082217S2, Exp 11/21/2017; 082317S2, Exp 11/22/2017 ; 082917S2, Exp 11/28/2019

Distribution pattern: Nationwide within the US

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility