Adrenalin epinephrine vials recalled nationwide due to temperature-abuse deviations
McKesson Medical-Surgical is recalling Adrenalin (epinephrine) 30 mL vials nationwide due to cGMP deviations involving temperature abuse during manufacturing. Temperature excursions may compromise drug 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: FDA Class II recall of a life-critical emergency medication. While no illnesses or deaths have been reported, temperature abuse of epinephrine could reduce drug potency, creating a risk of harm to patients relying on this medication in emergencies.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Adrenalin (epinephrine injection, USP) 30 mg/30 mL (1 mg/mL) multiple-dose vials. The recall affects 58 cartons distributed nationwide throughout the United States.
The recall was initiated due to cGMP deviations, specifically temperature abuse during manufacturing. Temperature excursions may affect the potency and safety of the drug.
Customers have been notified with distribution dates and shipment dates to help identify potentially affected product. McKesson Medical-Surgical was unable to identify specific lot numbers but has provided customers with timeframes to determine if their product may have been affected.
The recalled product
- Product
- ADRENALIN (EPINEPHRINE)
- Brand
- ADRENALIN
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Affected units
- 58
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.
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