The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0849-2023·Announced 2023-06-07

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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

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.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 86 recalled by Akorn, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 86 products in this recall →

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