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Recall Observatory FDA recall evidence

Drug product

fentanyl citrate (PF) 1100 mcg (20 mcg/mL) 55 mL syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025011001

D-0018-2018

October 10, 2017

Class II

Product summary

Firm
Banner Pharmacy Services, LLC
Event
Event 78227
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0018-2018

Official wording

Reason: Lack of Assurance of Sterility.

Code information: Lot # :051717S1, Exp 11/13/2017; 052417S1, Exp 11/20/2017; 062117S1, Exp 12/18/2017; 071217S1, Exp. 1/8/2017; 071917S1, Exp 1/15/2018; 072617S1, Exp 1/22/2018; 081017S1, Exp 2/6/2018

Distribution pattern: Nationwide within the US

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility