PlainRecalls
FDA Drug Moderate Class II Terminated

5% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml , b) 10ml dropper bottles

Reported: September 18, 2019 Initiated: September 3, 2019 #D-1855-2019

Product Description

5% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml , b) 10ml dropper bottles

Reason for Recall

Lack of Processing Controls:

Details

Units Affected
a) 4x5 ml, b) 1x10 ml bottles
Distribution
Product was dispensed to patients
Location
Monroe, CT

Frequently Asked Questions

What product was recalled?
5% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml , b) 10ml dropper bottles. Recalled by Compounded Solutions in Pharmacy. Units affected: a) 4x5 ml, b) 1x10 ml bottles.
Why was this product recalled?
Lack of Processing Controls:
Which agency issued this recall?
This recall was issued by the FDA Drug on September 18, 2019. Severity: Moderate. Recall number: D-1855-2019.