Drug & medication recalls Moderate risk

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

Recall date
September 3, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-1854-2019
FDA classification
Class II
Brand / firm
Compounded Solutions in Pharmacy
Sold / distributed
Product was dispensed to patients

Why it was recalled

Lack of Processing Controls:

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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