Cardinal Health Recalls Epinephrine Auto-Injectors Due to Temperature Excursions
Cardinal Health is recalling 414 boxes of Epinephrine auto-injectors distributed in Florida, Georgia, and South Carolina due to intermittent 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, 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, fitting the criteria for a moderate severity score.
Plain-English summary
Cardinal Health Inc. is recalling 414 boxes of Epinephrine Injection USP, 0.3mg auto-injectors. The product, manufactured for Teva Pharmaceuticals USA, Inc., is used for allergic emergencies (anaphylaxis) and includes 2 auto-injectors and 1 trainer per box. The affected product is identified by NDC 0093-5986-27 and code 033J20AA.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage. This condition may affect the stability and efficacy of the medication.
The affected units were distributed to Florida, Georgia, and South Carolina. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement. The recalling firm is Cardinal Health Inc.
The recalled product
- Product
- EPINEPHRINE (EPINEPHRINE)
- Brand
- EPINEPHRINE
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Injection
- Affected units
- 414
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)
- 033J20AA
UPCs (3)
- 0300935985275
- 0300935986272
- 009359862703
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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