Akorn Ketorolac Eye Drops Recalled Due to Manufacturing Quality Deviations
Akorn, Inc. is recalling all lots of Ketorolac Tromethamine Ophthalmic Solution 0.5% because the manufacturer went out of business and cannot complete required stability testing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II precautionary recall with no reported illnesses or injuries. The recall stems from a manufacturer's inability to complete required stability testing, representing a theoretical rather than confirmed hazard. Per the rubric, precautionary recalls without reported illnesses are rated Moderate.
Plain-English summary
Akorn, Inc. is recalling all lots of Ketorolac Tromethamine Ophthalmic Solution 0.5%, a prescription eye drop medication used to reduce eye inflammation and pain following eye surgery. The product is packaged in 3 mL, 5 mL, and 10 mL bottles and has been distributed nationwide in the United States and Puerto Rico.
The recall is being issued because Akorn, Inc. went out of business and can no longer conduct the stability studies required by FDA good manufacturing practice (CGMP) regulations. Stability testing ensures that a medication remains safe and effective throughout its approved shelf life. The firm's inability to complete these studies means the safety and efficacy of the product can no longer be verified.
Patients who are currently taking this eye drop should contact their healthcare provider or pharmacy to discuss alternative treatments. Healthcare facilities should stop dispensing this product and remove existing inventory from use.
The recalled product
- Product
- Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile, packaged in a) 3mL bottles, b bottles) 5 mL, and c)10 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Ophthalmic Solution
- Hazard
- cgmp-deviation
- stability-unknown
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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