Cardinal Health Recalls Orilissa Tablets Due to Temperature Excursions
Cardinal Health is recalling 210 cartons of Orilissa (elagolix) tablets 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 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Cardinal Health Inc. is recalling 210 cartons of Orilissa (elagolix) tablets, 150 mg, NDC 0074-0038-28. The recall was initiated because of current good manufacturing practice (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 product is 1120778. Orilissa is a prescription medication manufactured by AbbVie Inc.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider for further instructions. The FDA has classified this recall as Class II, meaning there is a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ORILISSA (ELAGOLIX)
- Brand
- ORILISSA
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 210
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)
- 1120778
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.
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