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

FDA Recall #D-1855-2019 — Class II — September 3, 2019

Recall #D-1855-2019 Date: September 3, 2019 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

Lack of Processing Controls:

Recalling Firm

Compounded Solutions in Pharmacy — Monroe, CT

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

a) 4x5 ml, b) 1x10 ml bottles

Distribution

Product was dispensed to patients

Code Information

Lots a) 07182019@29 exp: 8/31/19, 07082019@2 exp: 8/31/19, 06052019@21 exp:08/31/19 06062019@52 exp: 6/25/19; b) 07022019@28 exp: 8/31/19

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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