Quality Issues and Recall Events Lead to Drug Shortages

By Howard Aughinbaugh

When an over-the-counter drug is recalled, consumers are generally aware of the immediate impact. The recall process requires that affected products are removed from store shelves. Consumers are warned to discontinue use of the drug in order to protect themselves against any health risks the recalled drug may pose. But effective recall management also means that safe products quickly replace the recalled drugs in order to make sure that consumers always have the medications they need.

Unfortunately, recovery can be the most difficult part of the recall management process. A recent Chicago Tribune article reported that hospitals across the country are experiencing shortages of key medications as a result of manufacturing and quality control issues at major pharmaceutical companies. As a result, doctors many not always have the medicines they count on to treat their patients. Of particular concern are injectable medicines that have a longer production times than pills.

The FDA has recently been taking a more proactive approach to regulating the pharmaceutical industry, cracking down on quality issues such as toxins and particulate matter found in medicines. As the FDA works to ensure the safety of all drugs and medications, pharmaceutical and medical device manufacturers must make sure that the medicines and devices they make, as well as the processes they use to make them, are safe.

In addition to regular plant inspections and quality audits throughout the manufacturing process, your company should be reviewing its recall plans and regularly conducting mock recalls. Now is the time to prepare for a recall. Preparation is the key to effective recall management; allowing you to return to business as usual and getting your products back on store shelves and into the hands of doctors and hospitals quickly.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.