Narcan Nasal Spray Recalled for Temperature Excursions During Storage
Cardinal Health is recalling Narcan (naloxone hydrochloride) nasal spray 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, and the source text does not report any illnesses, injuries, or deaths. The hazard is a potential quality issue (temperature excursion) without confirmed harm, fitting the criteria for a moderate severity score.
Plain-English summary
Cardinal Health Inc. is recalling Narcan (naloxone hydrochloride) Nasal Spray 4 mg Two Pack. The recall involves 11,189 plungers of the product, which is distributed by Adapt Pharma, Inc. The affected units were distributed in Florida, Georgia, and South Carolina.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the product experienced intermittent exposure to temperature excursions during storage. This condition may affect the stability or quality of the medication.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The product is a prescription drug intended for intranasal use only.
The recalled product
- Product
- NARCAN (NALOXONE HYDROCHLORIDE)
- Brand
- NARCAN
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Nasal Spray
- Affected units
- 11,189
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)
- 201701
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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