Your descriptions may/can raise many issues.
To simply answer your original question in response to your statement "as a regulatory specialist," I would recommend and suggest that "one gets all surrounding facts (date, time, issues and by whom, etc.) and report to his/her supervisor as the first thing to do - which should be part of your organization's "issue/complaint escalation process." That should be the first step.
While doing so, please don't be judgemental or don't even get emotional - it is just the facts as part of business.
If you may allow me to go further, I will address the following.
Assuming it is a drug not concerning any device issues.
I interpret "CVS," which is equivalent to "health professionals."
When you say "need," I interpret it as "are we required..." To healthcare professionals, it is voluntary.
When you say "stability" issue, it involves quality issues, which is reportable voluntarily even if there is no injury or any patient involved (for example, Section 2 in MedWatch Form 3500B).
If you want to ask how I provide my advice on the matter to my clients, please let me know as it involves one's way of exercising consulting practices. In other words, my best practices may not be or even similar to yours.
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President and Principal
http://www.regulatorydoctor.com Riner VA
United States
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Original Message:
Sent: 09-30-2013 09:44
From: Amit Jain
Subject: Drug Product returned
Hello,
But if the product is returned because of "stability issue" still do we need to fill out the Medwatch from? {Note: there is no adverse event associated with the product.}
Thank you
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Amit Jain
United States
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Original Message:
Sent: 09-27-2013 17:31
From: Vikram Katragadda
Subject: Drug Product returned
Amit,
You can either complain manufacturer about the product that is at issue or send MedWatch report.
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Vikram Katragadda RAC
Senior Scientist
Lawrenceville NJ
United States
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Original Message:
Sent: 09-27-2013 14:55
From: Amit Jain
Subject: Drug Product returned
Hello All,
Need immediate thoughts on returned drug product,(from CVS)
As a regulatory specialist what will you do first? {e.g. filed complaint, CAPA, recalled, inform FDA}.
Please share your real time experience
Thank you
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Amit Jain
United States
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