The Recall Desk
ModerateFDA (Drugs)·D-0136-2023·Announced 2023-01-25

Ciprofloxacin ophthalmic solution recalled for manufacturing practice deviations

Akorn, Inc. is recalling 1,584 bottles of Ciprofloxacin Ophthalmic Solution nationwide due to Current Good Manufacturing Practice (CGMP) deviations. This is a voluntary recall.

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 drug recall for a voluntary precautionary recall due to manufacturing practice deviations with no reported illnesses or injuries, meeting the criteria for Moderate severity.

Plain-English summary

Akorn, Inc. is recalling 1,584 bottles of Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl) in 2.5mL bottles. The affected lot is identified as lot number 1E22A with an expiration date of October 31, 2022, and NDC number 17478-714-25.

The recall was initiated by the manufacturer on October 13, 2022, due to Current Good Manufacturing Practice (CGMP) deviations. The recalled product was distributed nationwide throughout the United States. The FDA formally classified this recall on January 13, 2023.

This is a voluntary recall by the manufacturer. No illnesses or injuries have been reported in connection with this product.

The recalled product

Product
Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-714-25
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic / Eye Solution
Hazard
Affected units
1,584

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 (2)

  • Lot: Lot 1E22A
  • EXP 10/31/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 27 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 27 products in this recall →

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