DICLOFENAC Sodium Ophthalmic Solution Recalled Due to Lack of Sterility Assurance

Plain-English summary

The product being recalled is Altaire Diclofenac Sodium Ophthalmic Solution (0.1%, 5 mL), a human prescription drug manufactured by Altaire Pharmaceuticals, Inc., distributed nationwide across the United States. The recall is initiated because the product lacks assurance of sterility, meaning it may not meet required sterile preparation standards and could pose an infection risk if used. Consumers are advised not to use this product until further notice. The manufacturer, Altaire Pharmaceuticals, Inc., is responsible for addressing the issue and ensuring future batches comply with sterility requirements.

According to the recall notice, the root cause is a lack of assurance of sterility, which represents a potential harm pathway for patients using this ophthalmic solution. While no illnesses or injuries have been reported to date, the absence of sterility assurance places this product in a risk-of-harm category where injury has not yet been documented.

The product quantity involved in this recall is 49,527 units. The recall affects all units distributed nationwide under recall number D-0461-2020. Consumers should discontinue use immediately and seek medical attention if they experience any adverse effects. The manufacturer will work to resolve the sterility assurance issue and provide updated information through official channels.

The recalled product

Product

DICLOFENAC (DICLOFENAC SODIUM)

Brand

DICLOFENAC

Manufacturer

Altaire Pharmaceuticals, Inc.

Category

Drug — Human Prescription Drug

Hazard

• sterility

Affected units

49,527

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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