Drug recalls occur more often than most people think. On average, there are about 4,500 drug recalls a year. Recalls occur in order to maintain the health and safety of its users. While they are usually minor, all recalls need to be taken seriously for the health and safety of the patient. Some of the reasons as to why a drug might be recalled include: mislabeling, contamination, or deviation in potency. Although the FDA oversees the process to ensure everything is handled in a timely manner, they rarely force a recall. It is important for all pharmacies to be familiar with the recall process, so they are prepared when it happens.
When a drug is recalled, there are three classifications it can fall under:
- Class I is a dangerous or defective product that could cause serious health problems or death.
- Class II is a product that might cause a temporary health problem or pose slight threat of a serious nature.
- Class III is a product that is unlikely to cause any adverse health reaction, but that violates FDA labeling or manufacturing laws
At Guaranteed Returns (GRx), we take care of your recalls in order to ensure your pharmacy is taking all the proper precautions when they occur. We receive notifications from FDA and US Recalls emails daily, as well as notices from vendors, wholesalers, and our customers. These are entered into our vendor policy system, and when the product is processed, it is returned to the manufacturer (or their 3PL) according to the recall policy on file. All you have to do is separate the recalled products from the rest of your inventory and notify your GRx representative when servicing your pharmacy. From there, GRx ensures the product stays separate for easy identification once returned to our warehouse. Mail-in customers should segregate the product (i.e., in a separate bag within the box) and include the recall notification with the product to ensure proper processing when it arrives here.
The most important aspects of recalls is that all staff members know where they can find an updated drug recall list on the FDA website. Since pharmacists are among the most trusted healthcare professionals, your staff should be properly educated on every recall and readily available for questions from patients.