Drug 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
D-0993-2022
Product summary
- Event
- Event 89646
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 cartons
- Official record key
drug-enforcement:D-0993-2022
Official wording
Reason: cGMP deviations: Temperature abuse
Code information: 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.
Distribution pattern: USA nationwide.
Derived failure modes
-
Manufacturing or process control
cGMP deviations