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Recall Observatory FDA recall evidence

Drug product

Cyclosporine (A) 0.1%; Cyclosporine (A) 0.2%; Cyclosporine (A) 1%; Cyclosporine (A) 2%; Cyclosporine (A) - Corn oil - 1% Oph solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

D-0200-2023

December 22, 2022

Class II

Product summary

Firm
Pharmacy Innovations
Event
Event 91332
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0200-2023

Official wording

Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Code information: t20221109@43 t20221108@27 t20221011@41 t20221024@3 t20221104@37 t20221025@32 t20221025@33 t20221013@15 t20221017@5

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility