COSOPT Ophthalmic Solution recall
COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate), 10 mL dropper bottle, Sterile, Rx only, Distributed by: Akorn, Inc., Lake Forest, IL, NDC: 17478-605-10
Why was COSOPT Ophthalmic Solution recalled?
Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
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: 426007 and 426008, exp 4/2020
- Product
- COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate), 10 mL dropper bottle, Sterile, Rx only, Distributed by: Akorn, Inc., Lake Forest, IL, NDC: 17478-605-10
- Recalling firm
- Akorn Inc
- Quantity
- 30,794 bottles
- Distribution
- Nationwide USA and Puerto Rico
- Recall date
- February 20, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)