PlainRecalls
FDA Drug Moderate Class II Terminated

Cyclosporin liquid 0.5%, Rx, plastic dropper bottle

Reported: January 9, 2019 Initiated: January 2, 2019 #D-0404-2019

Product Description

Cyclosporin liquid 0.5%, Rx, plastic dropper bottle

Reason for Recall

Lack of sterility assurance.

Details

Units Affected
N/A
Distribution
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.
Location
Roseburg, OR

Frequently Asked Questions

What product was recalled?
Cyclosporin liquid 0.5%, Rx, plastic dropper bottle. Recalled by Hiers Enterprises, LLC dba Northwest Compounding Pharmacy. Units affected: N/A.
Why was this product recalled?
Lack of sterility assurance.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 9, 2019. Severity: Moderate. Recall number: D-0404-2019.