Drug recall D-0993-2022

Class II Terminated reported Jun 15, 2022

Product

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

Reason for recall

cGMP deviations: Temperature abuse

Lots and codes

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.

Recall details

Recalling firm
Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA
Quantity
5 cartons
Distribution
USA nationwide.
Type
Voluntary: Firm initiated
Recall initiated
April 13, 2022
Terminated
November 30, 2023

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