Tobramycin Ophthalmic Solution Recalled Due to Incomplete Stability Studies
Akorn, Inc. is recalling all lots of Tobramycin Ophthalmic Solution 0.3% because the manufacturer went out of business and could not complete required stability studies, a violation of manufacturing regulations.
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 a risk-of-harm situation where stability studies required to confirm product safety were not completed due to manufacturer closure. No illnesses or injuries have been reported.
Plain-English summary
Akorn, Inc. is recalling all lots of Tobramycin Ophthalmic Solution, USP 0.3% (5mL bottles) distributed nationwide in the USA and Puerto Rico. The recall affects all lot codes.
The manufacturer went out of business and could no longer complete stability studies required by Current Good Manufacturing Practice (CGMP) regulations. This constitutes a deviation from manufacturing standards for pharmaceutical products.
Patients using this medication should contact their healthcare provider or pharmacist for guidance. Users should not discontinue this medication without consulting a healthcare professional first.
The recalled product
- Product
- Tobramycin Ophthalmic Solution, USP 0.3%, 5mL bottles, Rx only, Manufactured by: Akorn , Inc, Lake Forest, IL 60045. ALL NDCs
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Ophthalmic
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
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.
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