EPI-PEN 2-PAK (epinephrine injection, USP), Single-Dose Auto-Injectors 0.3 mg, Rx only, Manufactured for: Mylan Specialty LP., NDC 49502-500-02
Check against the official notice below — it lists the full affected range.
McKesson Medical-Surgical Inc. is recalling EPI-PEN 2-PAK (epinephrine injection, USP) 0.3 mg auto-injectors nationwide due to temperature abuse during manufacturing that violated current Good Manufacturing Practice standards. The recall involves 5 cartons of product that may have been shipped to customers between June 1 and September 30, 2021. Because McKesson cannot identify specific lot numbers for individual customers, affected consignees should check their own records to determine if they received any of these products during that timeframe and still have them in inventory.
The recall notification letter directs consignees to contact Sedgwick if they have questions about whether they received impacted product. The source document does not specify a remedy or next steps for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
cGMP deviations: Temperature abuse
Reason for recall: cGMP deviations: Temperature abuse Distribution: USA nationwide. Quantity: 5 cartons Lot/code info: McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer. The letters clearly explain that consignees should identify product received from MMS between June 1 and September 30, 2021. A consignee should be able to use its own records to determine whether it received an impacted product from MMS during that timeframe and whether it still has any of that product in inventory. The recall notification letter informs consignees that they may contact Sedgwick if they have any questions.
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.