Prescription EpiPen auto-injectors recalled for temperature-abuse manufacturing defect
McKesson Medical-Surgical is recalling EpiPen Jr epinephrine auto-injectors nationwide due to temperature exposure during manufacturing that may degrade medication potency.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall involving a risk-of-harm product (life-critical emergency medication) where no illnesses or injuries have been reported. Temperature-abused epinephrine may have reduced potency and could fail to treat anaphylaxis, a life-threatening emergency.
Plain-English summary
EpiPen Jr (epinephrine injection, USP) 0.15 mg auto-injectors in 2-count cartons are being recalled nationwide. The recall was initiated due to cGMP deviations, specifically temperature abuse during manufacturing and distribution. McKesson Medical-Surgical Inc. is coordinating the recall on behalf of the manufacturer.
Epinephrine auto-injectors are emergency medications used to treat severe allergic reactions and anaphylaxis. Temperature exposure can degrade epinephrine potency, potentially compromising the effectiveness of the medication when needed.
Patients and healthcare providers who have received this product should check recall notifications for distribution dates and lot number information. Do not use recalled auto-injectors. Contact your healthcare provider for replacement medication and to ensure you have a functional emergency anaphylaxis treatment plan in place.
The recalled product
- Product
- EPIPEN (EPINEPHRINE)
- Brand
- EPIPEN
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Emergency Medication
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office 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.
See all 130 products in this recall →Related recalls
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- HighEpiPen epinephrine auto-injectors recalled for manufacturing temperature deviation
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- CriticalEpiPen Jr. Auto-Injectors Recalled for Delivery System Defects
FDA (Drugs) · 2017-05-10
- CriticalEpiPen Auto-Injectors Recalled for Defective Delivery System
FDA (Drugs) · 2017-05-10
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