Merx is a well-respected pharmaceutical company. Due to an internal employee error, three batches of their most popular product, Youthasia, were shipped to pharmacies in May of 2020 which was one year after its expiration date of May 2019. Youthasia is a drug designed to treat aging. The product has a viable shelf life of 97% up to six months after manufacture if and only if the product is stored in a refrigeration unit. Otherwise, the shelf life of the product after expiration is unknown. Merx internal testing, under refrigeration, has revealed that after the six-month threshold is breached the product starts to loose effectiveness at a rate of one percent a month with mediocre effectiveness at 90%. Since FDA requirements for drug effectiveness are usually between 95-100%, Merx is currently performing research to increase the shelf life of this product.SEP. Fred purchased Youthasia in September of 2020. He used the product as instructed and saw no results. In a hurry to look younger and a bit disgruntled, he decided to consult his pharmacist. Upon further inspection, the pharmacist noticed the expiration date on the unrefrigerated stock bottle. Surprised she or her staff did not notice the expiration date sooner, the pharmacist decided to complain to Merx. Her complaints were unanswered. After many unanswered complaints, the pharmacist decided to consult the FDA. The FDA determined that the Youthasia tablets are adulterated and has ordered Merx to recall Youthasia, effectively taking Youthasia off the market.sep. 

Use the IRAC form to decipher whether or not the FDA's decision to label Youthasia as adulterated was reasonable?

Answer rating: 100% (QA)

Issue The issue is whether the FDAs decision to label Youthasia as adulterated was reasonable based on the facts and circumstances of the case Rule The rule is the relevant law or regulation that appl... View the full answer