FDA Recalls Epinephrine Auto-Injectors Due to Temperature Abuse
McKesson is recalling 55 packs of epinephrine auto-injectors nationwide due to temperature abuse during manufacturing. This represents a deviation from manufacturing standards.
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 risk-of-harm product—epinephrine auto-injectors are critical emergency medications—where no injury or illness has been reported. The hazard is theoretical rather than confirmed harm.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Epinephrine Injection, USP, Single-Dose Auto-Injectors (0.3 mg) due to cGMP deviations involving temperature abuse during manufacturing. The affected product was manufactured by Mylan Pharma and distributed nationwide in 55 packs.
Temperature exposure during manufacturing represents a deviation from Current Good Manufacturing Practice standards. Epinephrine is a critical emergency medication used to treat severe allergic reactions, and temperature deviations during manufacturing could affect product quality and efficacy.
McKesson Medical-Surgical Inc. was unable to identify specific lot numbers received by individual customers. The company has provided distribution dates in individual recall notifications to help customers identify potentially affected products. Customers who received affected products should contact McKesson Medical-Surgical Inc. for further instructions.
The recalled product
- Product
- EPINEPHRINE (EPINEPHRINE)
- Brand
- EPINEPHRINE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-abuse
Distribution
Distributed nationwide across the United States.
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