PlainRecalls
FDA Drug Moderate Class II Terminated

S-ATROPINE 0.01% OPHTHALMIC SOLUTION, packaged in a) 10ml and b) 50 ml dropper bottle, Rx only, Red Mountain Compounding RX.

Reported: November 13, 2019 Initiated: August 12, 2019 #D-0201-2020

Product Description

S-ATROPINE 0.01% OPHTHALMIC SOLUTION, packaged in a) 10ml and b) 50 ml dropper bottle, Rx only, Red Mountain Compounding RX.

Reason for Recall

Lack of Assurance of Sterility

Details

Units Affected
6x10 ml, 1x50 ml dropper bottle
Distribution
Nationwide in the USA
Location
Mesa, AZ

Frequently Asked Questions

What product was recalled?
S-ATROPINE 0.01% OPHTHALMIC SOLUTION, packaged in a) 10ml and b) 50 ml dropper bottle, Rx only, Red Mountain Compounding RX.. Recalled by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy. Units affected: 6x10 ml, 1x50 ml dropper bottle.
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-0201-2020.