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Recall Observatory FDA recall evidence

Drug product

Cyclosporine Injection, all strengths and all presentations including Cyclosporine 2% Aqueous Solution 15 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

D-356-2013

April 10, 2013

Class II

Product summary

Firm
FVS Holdings, Inc. dba. Green Valley Drugs
Event
Event 64879
Status
Terminated
Classification
Class II
Quantity
1 vial
Official record key
drug-enforcement:D-356-2013

Official wording

Reason: Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Code information: Lot #: 20130122-F, Exp 4/22/2013

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility