The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0146-2023·Announced 2023-01-25

Ofloxacin Ophthalmic Solution Recalled Nationwide for Manufacturing Quality Issues

Akorn, Inc. is recalling Ofloxacin Ophthalmic Solution 0.3% due to manufacturing quality deviations. The recall affects 65,006 bottles distributed nationwide.

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 voluntary recall due to manufacturing quality deviations with no reported illnesses or injuries documented in the source. Class II recalls indicate potential for adverse effects but lack reported incidents, fitting the Moderate category for voluntary precautionary recalls.

Plain-English summary

Akorn, Inc. is recalling Ofloxacin Ophthalmic Solution, USP 0.3% in 5 mL bottles (NDC: 13985-602-05) due to deviations from Current Good Manufacturing Practice (CGMP) standards. The recall affects 65,006 bottles that were distributed nationwide in the United States.

This is a Class II voluntary recall initiated by the manufacturer on October 13, 2022, after the firm identified manufacturing deviations in its production processes. The FDA formally classified the recall on January 13, 2023.

Patients currently using this medication should contact their healthcare provider or pharmacist regarding the recall. Do not stop using the medication without medical advice, as this is a prescription product requiring professional guidance. The affected lot numbers are 11B26A (expiration date 1/31/2023) and 1H02A (expiration date 7/31/2023).

Healthcare providers and patients can check the FDA's drug recall database for additional information and updates on this recall.

The recalled product

Product
Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: MWI, Boise, ID 83705. NDC: 13985-602-05
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic Solution
Hazard
Affected units
65,006

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 (4)

  • Lot: 11B26A
  • EXP 1/31/2023
  • 1H02A
  • EXP 7/31/2023

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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