Glucagon Emergency Kit Recalled for Temperature Abuse During Manufacturing
McKesson Medical-Surgical is recalling Glucagon Emergency Kits nationwide due to temperature abuse during manufacturing, which may affect drug efficacy. Patients should contact their healthcare provider.
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 designation with a manufacturing defect (temperature abuse) that creates risk-of-harm to patients dependent on this emergency medication. No illnesses or injuries have been reported, placing this in the risk-of-harm category without reported injury.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Glucagon Emergency Kits (1 mg per vial, manufactured by Eli Lilly) distributed throughout the United States. The recall is due to current Good Manufacturing Practice (cGMP) deviations involving temperature abuse during manufacturing.
Temperature exposure during manufacturing can potentially affect the stability and effectiveness of pharmaceutical products. Glucagon is used to treat severe hypoglycemia (low blood sugar) in emergency situations. Temperature-compromised medication may not work properly when needed in a medical emergency.
Patients and healthcare providers who have received this product should contact their pharmacy or doctor to determine if they have affected medication and to discuss next steps. McKesson Medical-Surgical is providing customers with specific distribution dates to help identify potentially affected shipments.
The recalled product
- Product
- Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial Diluent for Glucagon, 1ml syringe, Rx only, MFG: Eli Lilly, NDC 0002-8031-01
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Emergency Medication
- Hazard
- temperature-abuse
- manufacturing-defect
- product-degradation
Distribution
Distributed nationwide across the United States.
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