FDA-Drug2019-09-18Class II

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

Compounded Solutions in Pharmacy
Hazard

Lack of Processing Controls:

Sold states
Product was dispensed to patients
Affected count
a) 6x5ml b) 4x10 c) 1x15 ml bottles,
Manufactured in
810 Main St, Monroe, CT, United States
Products
10% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml, b) 10ml c) 15 ml, dropper bottles

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1854-2019

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