The Recall Desk
ModerateFDA (Drugs)·D-0481-2021·Announced 2021-06-02

Cardinal Health Recalls Trelegy Ellipta Due to Temperature Excursions

Cardinal Health Inc. is recalling 4,065 cartons of Trelegy Ellipta inhalers 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 due to CGMP deviations (temperature excursions) without reported injuries or illnesses, fitting the criteria for moderate severity involving low-risk contamination or voluntary precautionary measures.

Plain-English summary

Cardinal Health Inc. is recalling 4,065 cartons of Trelegy Ellipta (fluticasone furoate, umeclidinium bromide, and vilanterol trifenate) 100-62.5-25mcg 60-count inhalers. The recall was initiated due to CGMP deviations involving intermittent exposure to temperature excursions during storage.

The affected product is distributed in Florida, Georgia, and South Carolina. The specific lot code for the recalled units is FN2J. The product is a prescription medication used for respiratory conditions.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for a replacement. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
TRELEGY ELLIPTA (FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE)
Brand
TRELEGY ELLIPTA
Manufacturer
Cardinal Health Inc.
Category
Drug — Inhalation Powder
Hazard
Affected units
4,065

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)

  • FN2J

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 brand · TRELEGY ELLIPTA

Same manufacturer · Cardinal Health Inc.

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Same hazard · temperature excursion

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