PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: June 15, 2022 Initiated: April 13, 2022 #D-0993-2022

Product Description

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

Details

Units Affected
5 cartons
Distribution
USA nationwide.
Location
Richmond, VA

Frequently Asked Questions

What product was recalled?
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. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: 5 cartons.
Why was this product recalled?
cGMP deviations: Temperature abuse
Which agency issued this recall?
This recall was issued by the FDA Drug on June 15, 2022. Severity: Moderate. Recall number: D-0993-2022.