EpiPen epinephrine auto-injectors recalled for manufacturing temperature deviation
McKesson Medical-Surgical is recalling EpiPen 0.3 mg epinephrine auto-injectors due to temperature-related manufacturing deviations during the June-September 2021 distribution period.
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 with no reported illnesses or injuries. The hazard—temperature exposure during manufacturing—is a theoretical risk to product quality rather than a documented failure. Per the rubric, theoretical hazards without reported harm score at most 3 (High).
Plain-English summary
McKesson Medical-Surgical Inc. is recalling EpiPen (epinephrine injection, USP) 0.3 mg Single-Dose Auto-Injectors (EPI-PEN 2-PAK), manufactured for Mylan Specialty LP. The recalled products carry NDC 49502-500-02 and were distributed nationwide in the United States.
The recall is due to cGMP (current Good Manufacturing Practice) deviations identified as temperature abuse during manufacturing. The FDA classified this as a Class II recall. Products distributed to customers by McKesson Medical-Surgical between June 1 and September 30, 2021 may have been affected.
Consignees who received products from McKesson during the affected timeframe should use their own records to determine whether they received impacted product and whether any remains in inventory. The recall notification letter sent to each consignee includes the specific distribution dates for that customer. Consignees with questions may contact Sedgwick.
The recalled product
- Product
- EPIPEN (EPINEPHRINE)
- Brand
- EPIPEN
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-abuse
- manufacturing-deviation
Distribution
Distributed nationwide across the United States.
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