FDAClass IISeptember 18, 2019

5% Acetyl-L-Cysteine Ophthalmic Solutions recall

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

Why was 5% Acetyl-L-Cysteine Ophthalmic Solutions recalled?

Lack of Processing Controls:

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
5% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml , b) 10ml dropper bottles
Recalling firm
Compounded Solutions in Pharmacy
Quantity
a) 4x5 ml, b) 1x10 ml bottles
Distribution
Product was dispensed to patients
Recall date
September 18, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls