market withdrawal

market withdrawal

A process that is triggered when a healthcare product with a minor violation that would not normally be subject to FDA legal action is temporarily or permanently removed from the market to correct said violation. 

Example
A product—often of a particular lot number—which is removed from the market due to tampering, without evidence of manufacturing or distribution problems.
References in periodicals archive ?
The outcomes of analysis will determine the next cause of action including market withdrawal of any substandard products,'Kebs said in a statement.
class="MsoNormalMeanwhile, the Kenya Bureau of Standards (Kebs) said it has launched investigations into the complaints, and that "the outcomes of the analysis will determine the next course of action, including market withdrawal of any substandard products.
Eye care specialist Alcon, a division of Novartis (SWX: NOVN), announced on Wednesday a voluntary global market withdrawal of its CyPass Micro-Stent for glaucoma treatment.
Reflecting its uncompromising commitment to patient safety, Alcon today announced an immediate, voluntary market withdrawal of the CyPass Micro-Stent from the global market.
(2,3) Drugs promoted via DTCA are often early in their product lifecycle and sometimes subsequently manifest serious harms leading to market withdrawal. (4) Various benefits have been claimed for DTCA, including patient empowerment, informed decision-making and reduced disease-related stigma.
'No other requests of market withdrawal or license suspension have been received from other NRAs where the vaccine is approved,' it added.
The Evergreen Health individual market withdrawal will affect about 6,000 holders of the company's individual and family coverage, officials say in a set of answers for consumers.
EU member states could also utilize other legal and commercial instruments such as injunctions, market withdrawal and product confiscation.
On January 21, 2016, Company A voluntarily halted production at its Ohio facility and conducted a market withdrawal of all packaged salad products from that facility because of possible Listeria contamination.
He noted if, on the other hand, a market withdrawal is due to loss activity and poor results, "it takes a management team and board that is willing and has the conviction to enter markets in which everyone else is saying they aren't making money."
If an insurer changes all of its products in a market so much that it looks as if the insurer has discontinued all of the old products, "the issuer has effectuated a market withdrawal under federal law," officials say.
Aside from damaging a manufacturer's or importer's reputation, the lack of compliance with FCC requirements can lead to significant monetary fines, market withdrawal and a request to readdress the entire product qualification process.