PlainRecalls
FDA Drug Moderate Class II Terminated

S-BENZALKONIUM CHLORIDE 0.013% SOLUTION, 1000ml plastic container, For irrigation use only, Rx only, Red Mountain Compounding Rx.

Reported: November 13, 2019 Initiated: August 12, 2019 #D-0205-2020

Product Description

S-BENZALKONIUM CHLORIDE 0.013% SOLUTION, 1000ml plastic container, For irrigation use only, Rx only, Red Mountain Compounding Rx.

Reason for Recall

Lack of Assurance of Sterility

Details

Units Affected
4x1000 plastic containers
Distribution
Nationwide in the USA
Location
Mesa, AZ

Frequently Asked Questions

What product was recalled?
S-BENZALKONIUM CHLORIDE 0.013% SOLUTION, 1000ml plastic container, For irrigation use only, Rx only, Red Mountain Compounding Rx.. Recalled by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy. Units affected: 4x1000 plastic containers.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on November 13, 2019. Severity: Moderate. Recall number: D-0205-2020.