The Recall Desk
ModerateFDA (Drugs)·D-0534-2021·Announced 2021-06-02

Cardinal Health Recalls Ilevro Ophthalmic Suspension Due to Temperature Excursions

Cardinal Health Inc. is recalling Ilevro (nepafenac ophthalmic suspension) 0.3% due to intermittent exposure to temperature excursions during storage.

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: The recall is classified as FDA Class II and involves a CGMP deviation (temperature excursion) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Cardinal Health Inc. is recalling 348 droptainers of Ilevro (nepafenac ophthalmic suspension) 0.3%, 3 mL, sterile, prescription only. The product is manufactured by Alcon Laboratories, Inc. The recall is being conducted because of Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage.

The affected product is identified by the code 10CPE and NDC 0065-1750-14. The recall is classified as Class II by the U.S. Food and Drug Administration. The product was distributed to Florida, Georgia, and South Carolina.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
Ilevro (nepafenac ophthalmic suspension) 0.3% 3 mL Sterile Rx Only NDC 0065-1750-14 Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134
Manufacturer
Cardinal Health Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
348

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)

  • 10CPE

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 198 recalled by Cardinal Health 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 198 products in this recall →

Related recalls

Same manufacturer · Cardinal Health Inc.

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Same hazard · temperature excursion

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