Moxifloxacin HCl Ophthalmic Solution Recalled Due to CGMP Compliance Deviation
Moxifloxacin HCl Ophthalmic Solution 0.5% is being recalled because manufacturer Akorn, Inc. ceased operations and cannot complete required stability studies. All lots distributed nationwide in the USA and Puerto Rico are affected.
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 FDA recall without reported illnesses or injuries. The recall is driven by manufacturing compliance issues and the firm's inability to complete stability studies following business closure, rather than by documented product defects or contamination. The hazard is theoretical without evidence of actual harm.
Plain-English summary
Moxifloxacin HCl Ophthalmic Solution, USP, 0.5% manufactured by Akorn, Inc. is being recalled. The product was distributed nationwide in the USA and Puerto Rico in 3 mL bottles.
The recall is due to a deviation from current Good Manufacturing Practice (CGMP) standards. Specifically, the manufacturing firm went out of business and could no longer continue the stability studies required for pharmaceutical products. Stability studies are essential to verify that a medication maintains its potency and safety throughout its shelf life.
Patients currently using this medication should contact their healthcare provider to determine whether an alternative ophthalmic medication is appropriate for their needs. Healthcare providers should direct patients to alternative treatment options.
The recalled product
- Product
- Moxifloxacin HCl Ophthalmic Solution, USP, 0.5%, 3 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
- Manufacturer
- Akorn, Inc.
- Hazard
- cgmp-deviation
- stability-verification
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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