Cardinal Health Recalls Butorphanol Tartrate Nasal Solution Due to Temperature Excursions
Cardinal Health Inc. is recalling 38 bottles of Butorphanol Tartrate Nasal Solution due to intermittent 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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Cardinal Health Inc. is recalling 38 bottles of Butorphanol Tartrate Nasal Solution USP 10 mg/mL, 2.5 mL bottles. The product is identified by NDC 60505-0813-1 and lot code RT7113. It was manufactured by Apotex Inc. in Toronto, Ontario, Canada.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage. The affected units were distributed to Florida, Georgia, and South Carolina.
Consumers and healthcare providers should discontinue use of the recalled product and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- BUTORPHANOL TARTRATE (BUTORPHANOL TARTRATE)
- Brand
- BUTORPHANOL TARTRATE
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Nasal Solution
- Hazard
- Affected units
- 38
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)
- RT7113
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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