10% Acetyl-L-Cysteine Ophthalmic Solutions recall
10% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml, b) 10ml c) 15 ml, dropper bottles
Why was 10% 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) 08012019@33 exp: 8/15/19, 07182019@66 exp: 8/01/19, 07182019@15 exp: 8/01/19, 07012019@46 exp. 08/31/19, 07082019@27 exp: 8/31/19, b) 07082019@55 exp: 8/31/19; 07182019@55 exp: 08/31/19; 06242019@55 exp: 8/31/19; 06202019@16 exp: 8/31/19 c) 08052019@11 exp: 11/3/19
- Product
- 10% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml, b) 10ml c) 15 ml, dropper bottles
- Recalling firm
- Compounded Solutions in Pharmacy
- Quantity
- a) 6x5ml b) 4x10 c) 1x15 ml bottles,
- Distribution
- Product was dispensed to patients
- Recall date
- September 18, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)