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Recall Observatory FDA recall evidence

Drug product

ePHEDrine sulfate 50 mg/10 ml syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025024801

D-0016-2018

October 10, 2017

Class II

Product summary

Firm
Banner Pharmacy Services, LLC
Event
Event 78227
Status
Terminated
Classification
Class II
Quantity
972 syringes
Official record key
drug-enforcement:D-0016-2018

Official wording

Reason: Lack of Assurance of Sterility.

Code information: Lot #: 072717S1, Exp 10/25/2017; 080217S1, 10/31/2017; 081517S2, Exp 11/13/2017; 082917S1, Exp 11/27/2017.

Distribution pattern: Nationwide within the US

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility