Epinephrine Auto-Injector Recalled for Temperature Abuse During Manufacturing and Distribution
Epinephrine auto-injectors distributed nationwide are being recalled due to temperature abuse during manufacturing. Temperature exposure may degrade the medication and reduce its emergency effectiveness.
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 FDA recall of a risk-of-harm product (epinephrine auto-injectors for emergency anaphylaxis treatment) with no reported illnesses or injuries. Per the severity rubric, recalls involving risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
McKesson Medical-Surgical is recalling approximately 30 packs of Epinephrine Injection, USP, Single-Dose Auto-Injectors (0.15 mg, 2-count cartons) that were distributed nationwide. The recall was initiated due to cGMP deviations: temperature abuse during manufacturing and distribution of the product.
Epinephrine is a prescription emergency medication used to treat severe allergic reactions and anaphylaxis. Temperature exposure during manufacturing and distribution may cause the medication to degrade. McKesson was unable to identify specific lot numbers for individual consignees and instead notified customers with the dates affected product may have been shipped to them.
Patients and healthcare providers who have this recalled product should contact McKesson Medical-Surgical or their healthcare provider about replacement options and appropriate next steps.
The recalled product
- Product
- EPINEPHRINE (EPINEPHRINE)
- Brand
- EPINEPHRINE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug
- Hazard
- temperature-abuse
- manufacturing-defect
- loss-of-efficacy
Distribution
Distributed nationwide across the United States.
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