Cardinal Health Recalls Trelegy Ellipta Inhalers Due to Temperature Excursions
Cardinal Health is recalling 903 Trelegy Ellipta inhalers distributed in Florida, Georgia, and South Carolina 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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a CGMP deviation (temperature excursion) without reported harm, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Cardinal Health Inc. is recalling 903 units of Trelegy Ellipta (fluticasone furoate, umeclidinium bromide, and vilanterol trifenate) 100 mcg/62.5 mcg/25 mcg inhalers. The affected product is identified by lot code 3X8P and NDC 0173-0887-10. The recall was initiated because the inhalers experienced intermittent exposure to temperature excursions during storage, which constitutes a deviation from Current Good Manufacturing Practices (CGMP).
The affected inhalers were distributed to Florida, Georgia, and South Carolina. Trelegy Ellipta is a prescription medication used for the maintenance treatment of chronic obstructive pulmonary disease (COPD).
Consumers who have this specific 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 situation where use of, or exposure to, the violative 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
- Affected units
- 903
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)
- 3X8P
Distribution
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
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