Akorn Tropicamide Ophthalmic Solution Recalled for Manufacturing Quality Deviations
Akorn recalls all lots of Tropicamide Ophthalmic Solution 0.5% (15 mL bottles) nationwide due to CGMP deviations. The firm was unable to complete required stability studies after ceasing operations.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving CGMP deviations and incomplete stability studies, representing a risk-of-harm situation where product quality assurance could not be completed. No illnesses or injuries have been reported, but the inability to verify stability means the safety and efficacy profile remains uncertain.
Plain-English summary
Akorn Operating Company LLC is recalling all lots of Tropicamide Ophthalmic Solution, USP 0.5%, distributed in 15 mL bottles (Rx only). The recall affects products distributed nationwide in the United States and Puerto Rico.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The manufacturer went out of business and could no longer continue the stability studies required to ensure the product maintains its safety and efficacy throughout its labeled shelf life.
Tropicamide is a prescription eye drop used to dilate the pupil during diagnostic eye exams and certain ophthalmic procedures. Patients who possess this product should contact their prescribing eye care provider or pharmacist for guidance on safe alternatives or proper product disposition. Do not use the product without first consulting a healthcare provider.
The recalled product
- Product
- Tropicamide Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Ophthalmic Solution
- Hazard
- cgmp-deviation
- incomplete-stability-studies
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots
Distribution
Distributed nationwide across the United States.
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