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
Reported: February 20, 2019 Initiated: December 20, 2018 #D-0483-2019
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
Reason for Recall
Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
Details
- Recalling Firm
- Akorn Inc
- Units Affected
- 30,794 bottles
- Distribution
- Nationwide USA and Puerto Rico
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Akorn Inc. Units affected: 30,794 bottles.
Why was this product recalled? ▼
Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 20, 2019. Severity: Low. Recall number: D-0483-2019.
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