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Recall Observatory FDA recall evidence

Drug product

Cyclosporin liquid 2%, Rx, plastic dropper bottle, dry eye

D-0392-2019

January 02, 2019

Class II

Product summary

Firm
Hiers Enterprises, LLC dba Northwest Compounding Pharmacy
Event
Event 81883
Status
Terminated
Classification
Class II
Quantity
830 ml
Official record key
drug-enforcement:D-0392-2019

Official wording

Reason: Lack of sterility assurance.

Code information: 08172018@7 exp 2/13/19, 09202018@16 exp 3/2/19, 10172018@32 exp 3/2/19.

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