Company X markets a product that is showing migration of the active ingredient between tablets at 18 months. (The product label specifies that the tablets have a shelf life of 3 years.) Testing performed at the 18 month stability interval revealed that some tablets contain twice as much active ingredient as listed on the labelother tablets contain little or no active ingredient and are believed to have no efficacy. The medication is used to prevent heart attacks and is taken immediately after onset of symptoms. Questions IS A PRODUCT RECALL JUSTIFIED?