PlainRecalls
FDA Drug Moderate Class II Terminated

10% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml, b) 10ml c) 15 ml, dropper bottles

Reported: September 18, 2019 Initiated: September 3, 2019 #D-1854-2019

Product Description

10% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml, b) 10ml c) 15 ml, dropper bottles

Reason for Recall

Lack of Processing Controls:

Details

Units Affected
a) 6x5ml b) 4x10 c) 1x15 ml bottles,
Distribution
Product was dispensed to patients
Location
Monroe, CT

Frequently Asked Questions

What product was recalled?
10% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml, b) 10ml c) 15 ml, dropper bottles. Recalled by Compounded Solutions in Pharmacy. Units affected: a) 6x5ml b) 4x10 c) 1x15 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-1854-2019.