Hydrocodone Acetaminophen Case

Words: 1597
Pages: 7

Hydrocodone/acetaminophen is a narcotic drug used as analgesics. This pain killer has two active ingredients and are usually dispensed as tablets and oral solutions. According to the FDA product supply website, there are 19 existing suppliers for hydrocodone acetaminophen. They include: Vintage Pharms, Mallinckrodt, Milkart, Amneal Pharms NY, Pharm Association, Sun Pharm INDS INC, VistaPharm, Aurolife Pharma LCC, Tris Pharma INC, Larken Labs INC, Rhodes Pharms, Par Pharm, Novel Labs INC, Actavis Labs FL INC, Upsher Smith Labs, Amneal Pharms, Lannett Holdings INC, Abhai LLC, and Wes Pharma INC. (FDA) For the purpose of this case study, the quality of each supplier will be assessed and complied into a scorecard to determines the best and the worst supplier(s) for consumer’s reference. Quality can be defined as a system of standards that assess the value and performance of a drug product comparative to another. A scorecard is a tool used to help measure and rank in various categories based on established standards. In combination, a quality scorecard is a tool used to aid in …show more content…
FDA warning letters are issued by the FDA to manufacturer when a violation of FDA regulation has occurred. The letter states the violation and provides direction and timeframe for the correction. Companies with records of warning letters could be least reliable in producing good quality products and more prone for future recalls. For scoring, 10 points are given to suppliers without warning letters and 0 points to those that had warning letters. From the FDA websites, 4 warning letters have been given to 4 different suppliers of hydrocodone acetaminophen. However, those suppliers have all discontinued their production. Therefore, records of warning letters are not a good element to rank existing suppliers in the case of hydrocodone acetaminophen. All the suppliers from our list have receive 10 points for this