Cardinal Health Recalls EpiPen Auto-Injectors Due to Temperature Excursions
Cardinal Health is recalling 620 EpiPen auto-injectors distributed in Florida, Georgia, and South Carolina due to intermittent temperature exposure 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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a theoretical risk of reduced efficacy due to storage conditions, which aligns with the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls without reported harm.
Plain-English summary
Cardinal Health Inc. is recalling 620 units of EpiPen (epinephrine) auto-injectors. The affected products include various strengths, packs, and styles manufactured for Mylan Specialty L.P. The specific lot code is 0FM544, and the products are identified by NDCs 9502-500-01, 49502-500-02, 49502-500-92, and 49502-501-01.
The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage. This condition may compromise the stability and efficacy of the epinephrine medication.
The affected units were distributed in Florida, Georgia, and South Carolina. Consumers and healthcare providers should check their inventory for the specific lot code and NDCs listed above. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement, or reported to the recalling firm.
The recalled product
- Product
- EPIPEN (EPINEPHRINE)
- Brand
- EPIPEN
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Injection
- Affected units
- 620
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)
- 0FM544
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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