The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0445-2021·Announced 2021-06-02

Cardinal Health Recalls MURO-128 Eye Drops Due to Temperature Excursions

Cardinal Health is recalling MURO-128 2% eye drops due to intermittent temperature excursions during storage. The affected units were distributed in Florida, Georgia, and South Carolina.

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: The recall is classified as FDA Class II due to CGMP deviations (temperature excursions) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Cardinal Health Inc. is recalling 64 droptainers of MURO-128 2% 15ML OPTH eye drops. The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage.

The affected product is identified by NDC/UPC 324208276150. All lots were distributed between February 23, 2021, and March 10, 2021. The distribution pattern indicates the product was available in Florida, Georgia, and South Carolina.

Consumers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions. This recall is classified as FDA Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
MURO-128 2% 15ML OPTH; NDC/UPC 324208276150; OTC; DROPS
Manufacturer
Cardinal Health Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
64

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)

  • All Lots distributed 02/23/2021 through 03/10/2021.

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 →

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