The Recall Desk
HighFDA (Drugs)·D-0851-2023·Announced 2023-06-07

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.

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 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
Hazard
  • cgmp-violation
  • incomplete-stability-study

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.

Related recalls

Same category