Timolol Maleate Ophthalmic Solution Recalled for Manufacturing and Stability Testing Defects
Akorn, Inc. has recalled all lots of Timolol Maleate Ophthalmic Solution 0.5% nationwide due to manufacturing quality deviations and inability to complete stability studies.
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 FDA Class II recall involves no reported illnesses or injuries. However, the inability to complete stability studies due to the manufacturer going out of business creates a risk of unknown drug safety and efficacy over time, meeting the rubric criterion for High severity: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Akorn, Inc. is recalling all lots of Timolol Maleate Ophthalmic Solution, USP 0.5%, packaged in bottles of 2.5mL, 5mL, 10mL, and 15mL. The product is distributed nationwide in the United States and Puerto Rico.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The manufacturing firm went out of business and was unable to continue the stability studies required to verify that the product maintains its safety and effectiveness over its intended shelf life.
Patients currently using this ophthalmic solution should contact their healthcare provider or pharmacist for guidance. This is a prescription medication, and any questions regarding treatment should be discussed with the prescribing physician.
The recalled product
- Product
- Timolol Maleate Ophthalmic Solution, USP 0.5%, packaged in a) 2.5mL bottles, b) 5mL bottles, c) 10 mL bottles, and d)15mL bottles, Rx only, Manufactured by: Akorn , Inc, Lake Forest, IL 60045. ALL NDCs
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Ophthalmic / Eye Drops
- Hazard
- manufacturing-defect
- incomplete-stability-testing
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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