I agree with most of the participants regarding product recall due to a device failure. Product recall is the worst thing that can happen to a medical device company. It can affect the business assets, the people involved and the end client. In this particular situation, change control procedures should have been followed by the company. It is required by ISO 13485 that the medical device company to have the change control procedure such as an Engineering Change Notice (ECN). It is used to make changes in the process after design control has been completed and almost ready for productions. After the 1st prototype lot, there should be a design review meeting to discuss any failures. Mylan should’ve had a meeting with the engineers and the design review team to review the manufacturing process and specification of EpiPen and EpiPen Jr. All in all, product recall can really put the project back to as early as planning and can really hurt the company financially.