Hello Samirabanu,
It does depend on the market you are speaking about because there can be slight differences in the definitions and terms which are used for recalling a product. As an example, the terms product withdrawal, product correction, and market withdrawal are described in U.S. FDA in 21 CFR 803 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-803. So for example, a Product Withdrawal would be the physical removal of product from the market - this could be distributors or end users. A Product Withdrawal is done in the U.S. when the device is not conforming to requirements - commonly called a Recall. A Market Withdrawal would be when the device is conforming to requirements and the organisation decides to physical retrieve the product for some other reason. This could be the product is removed from the market or maybe a new version has been introduced so the previous version is being taken back from the market. It is always beneficial to read the regulations and guidance documents which provides definitions or explanation of terms - and again this depends on the regulatory requirements for each country or region.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE
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Original Message:
Sent: 31-Jan-2024 23:17
From: Anne LeBlanc
Subject: Recall
Hello Samirabanu
Health Canada defines recall as "A responsible party's removal from further sale or use, or correction, of a distributed product that presents a risk to the health of consumers or violates the Act or the Regulations" and withdrawal as "The removal from further sale or use or correction of a distributed product where there is no health and safety risk and no contravention of the legislation or regulations. It is not considered to be a recall."
Type III recalls are "where the use of (or exposure to) a recalled product is not likely to cause any adverse health consequences."
Products can be out of compliance without being unsafe (type III). And manufacturers can choose voluntarily to pull back products from the market when there is no safety or compliance problem (withdrawal).
https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/recalls/guidance-drug-natural-health-products/document.html
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Anne LeBlanc
United States
Original Message:
Sent: 31-Jan-2024 22:45
From: Samirabanu Shaikh
Subject: Recall
Hello everyone,
I hope you are doing well.
Can anyone tell me the difference between Product withdrawal and Market Withdrawal with a few examples? As well, what is the difference between Market withdrawal and the Recall-III category with a few examples?
Thank you.
Best regards,
Samira
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Samirabanu Shaikh
Toronto ON
Canada
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