The Recall Desk
ModerateFDA (Drugs)·D-0408-2021·Announced 2021-06-02

Cardinal Health Recalls Ofloxacin Eye Drops Due to Temperature Excursions

Cardinal Health Inc. is recalling 339 bottles of Ofloxacin 0.3% eye drops due to intermittent 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 the hazard 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 339 bottles of Ofloxacin 0.3% 5ml ophthalmic drops (NDC 17478071310). The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage.

The affected product was distributed in Florida, Georgia, and South Carolina. The specific lot code for the recalled items is 427297.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product
OFLOXACIN 0.3% 5ML OPTH; NDC/UPC 17478071310; RX; DROPS
Manufacturer
Cardinal Health Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
339

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)

  • 427297

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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