The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0829-2023·Announced 2023-06-07

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.

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 2/5 (Moderate).

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.
Category
Drug — Ophthalmic / Eye Medication
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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