Cardinal Health Recalls Chantix Tablets Due to Temperature Excursions
Cardinal Health is recalling 940 cartons of Chantix (varenicline) tablets due to intermittent temperature excursions during storage. The affected products were distributed in Florida, Georgia, and South Carolina.
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 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 940 cartons of Chantix (varenicline) Tablets, 1 mg, 56 tablets per box. The recall is due to CGMP deviations involving intermittent exposure to temperature excursions during storage. The affected product is identified by lot code EC5910 and NDC 0069-0469-03.
The recalled products were distributed in Florida, Georgia, and South Carolina. Chantix is a prescription medication used for smoking cessation.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for a replacement or further instructions. The recall is classified as FDA Class II.
The recalled product
- Product
- Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x 56 tablets) Rx only NDC 0069-0469-03 Distributed by Pfizer Labs Division of Pfizer Inc., NY, NY 10017
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 940
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)
- EC5910
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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