Why it was recalled
Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
Product description
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
Lot numbers, UPCs & expiration codes
Lots: 426007 and 426008, exp 4/2020
Where it was sold
Nationwide USA and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0483-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 20, 2018
- FDA report date
- Feb 20, 2019
- Quantity
- 30,794 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn Inc
Original FDA data
Every field from FDA enforcement report D-0483-2019, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 81836
- Address
- 1925 W Field Ct Ste 300
- Code information
- Lots: 426007 and 426008, exp 4/2020
- Postal code
- 60045-4862
- Report date
- Feb 20, 2019
- Product type
- Drugs
- Recall number
- D-0483-2019
- Classification
- Class III
- Recalling firm
- Akorn Inc
- Product quantity
- 30,794 bottles
- Termination date
- Nov 6, 2020
- Reason for recall
- Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide USA and Puerto Rico
- Recall initiation date
- Dec 20, 2018
- Initial firm notification
- Letter
- Center classification date
- Feb 8, 2019