Cardinal Health Recalls Buprenorphine and Naloxone Sublingual Film Due to Temperature Excursions
Cardinal Health Inc. is recalling 249 cartons of Buprenorphine and Naloxone Sublingual Film 4mg/1mg due to intermittent exposure to temperature excursions during storage.
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 involving temperature excursions. Per the rubric, this falls under moderate severity as it involves a potential quality issue without reported injuries or illnesses, and the hazard is theoretical or low-risk contamination.
Plain-English summary
Cardinal Health Inc. is recalling 249 cartons of Buprenorphine and Naloxone Sublingual Film 4mg/1mg (NDC/UPC 47781-0356-03). The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage.
The affected product was distributed in Florida, Georgia, and South Carolina. The source text does not specify the exact dates of distribution or the specific lot numbers involved beyond the provided code information.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for guidance on replacement or disposal. The FDA classifies this recall as 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
- BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM 4MG/1MG 30 POUCHES EACH CONTAINING 1 SUBLINGUAL FILM NDC/UPC 47781-0356-03; RX; FILM
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Sublingual Film
- Affected units
- 249
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)
- 37890
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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