FDA Drug Moderate Class II Terminated

Lidocaine/Epinepherine liquid 1%/ 1:1000, RX, glass vial These include injectable medications, sterile solutions, eye drops, and eye ointments

Reported: January 9, 2019 Initiated: January 2, 2019 #D-0398-2019

Product Description

Reason for Recall

Lack of sterility assurance.

Details

Recalling Firm: Hiers Enterprises, LLC dba Northwest Compounding Pharmacy
Units Affected: 50 ml
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? ▼

Lidocaine/Epinepherine liquid 1%/ 1:1000, RX, glass vial These include injectable medications, sterile solutions, eye drops, and eye ointments. Recalled by Hiers Enterprises, LLC dba Northwest Compounding Pharmacy. Units affected: 50 ml.

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-0398-2019.