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Recall Observatory FDA recall evidence

Drug 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

D-0483-2019

December 20, 2018

Class III

Product summary

Firm
Akorn Inc
Event
Event 81836
Status
Terminated
Classification
Class III
Quantity
30,794 bottles
Official record key
drug-enforcement:D-0483-2019

Official wording

Reason: Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.

Code information: Lots: 426007 and 426008, exp 4/2020

Distribution pattern: Nationwide USA and Puerto Rico

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification