Hiers Enterprises, LLC dba Northwest Compounding Pharmacy recalls Cyclosporin liquid 0.5%, Rx, plastic dropper bottle

Recall date

January 2, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0404-2019

FDA classification

Class II

Brand / firm

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Sold / distributed

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.

Why it was recalled

Lack of sterility assurance.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Cyclosporin liquid 0.5%, Rx, plastic dropper bottle