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Recall Observatory FDA recall evidence

Drug product

Cyclosporin liquid 0.5%, Rx, plastic dropper bottle

D-0404-2019

January 02, 2019

Class II

Product summary

Firm
Hiers Enterprises, LLC dba Northwest Compounding Pharmacy
Event
Event 81883
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0404-2019

Official wording

Reason: Lack of sterility assurance.

Code information: 07272018@2

Distribution pattern: Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of sterility