Glucagen Injectable Medication Recalled Nationwide for Temperature Abuse
McKesson Medical-Surgical is recalling Glucagen (glucagon) 1 mg injection vials nationwide due to temperature abuse during manufacturing and distribution, a cGMP deviation.
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 classified this as a Class II recall due to cGMP deviations from temperature abuse. Although no illnesses or injuries have been reported, this recall affects a pharmaceutical product where manufacturing defects could compromise drug stability and efficacy, qualifying it as a risk-of-harm product.
Plain-English summary
Glucagen (glucagon) for injection is being recalled nationwide by McKesson Medical-Surgical Inc. due to cGMP deviations caused by temperature abuse. The product is supplied as 1 mg per vial in 10-vial cartons.
Temperature abuse during manufacturing and distribution may affect pharmaceutical product quality and stability. Individuals and healthcare facilities that have received this product should not use it and should contact McKesson Medical-Surgical for return authorization and replacement product.
McKesson Medical-Surgical has notified affected customers with specific lot numbers and the distribution dates when the product may have been received.
The recalled product
- Product
- Glucagen (glucagon) for injection, packaged in a 10-count box, (10 vials each containing 1 mg per vial), Rx only, MFG: Boehringer Mannheim, NDC 0597-0053-45
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Injectable
- Hazard
- temperature-abuse
- cgmp-deviation
Distribution
Distributed nationwide across the United States.
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