Drug Recalls: A 3-Step Patient Guide

by Jenny Bingham, PharmD, BCACP
SinfoníaRx

December 31, 2018

drug-recalls

Have you ever experienced the unsettling feeling when you hear a drug recall announcement for a prescription that you take every day? The United States Food & Drug Administration (FDA) recalled over seven different products in December 2018 due to impurities, mislabeling, or performance defects. The FDA works closely with drug manufacturers to recall and remove any defective medications from the consumer market.  They also have laws that require organizations to contact patients subject to the recall.

If you do find yourself not knowing what next steps to take after a drug recall, here are some useful tips to guide you throughout the process.

Step 1: Resources for Recalled Medications

The FDA publicly shares a current listing of all recalled products on their website. If you receive a phone call, email, mailer, or any type of communication from your dispensing pharmacy and/or organization that administers your medication to you, you can use this website to learn more information about the recall and the reason for it.

Patients can also contact their dispensing pharmacy to confirm whether their medication was subject to the recall. Most pharmacies keep a digital log of the lot number, expiration date, and NDC. They can compare it to the FDA’s drug recall tracking information (as shown below), along with product photos on their website.

NDC Manufacturer Product
Description
Lot/Batch Expiration
Date

The FDA classifies drug recalls based on their severity. Class I Recalls pose a risk for serious health problems and death. Class II Recalls pose a risk of temporary or reversible health problems. Class III Recalls are not likely to cause an adverse health problem, but it violated FDA laws. Only your provider can determine what is the best course of action to take in response to the recall.

Step 2: Contact Your Provider

Whether your provider is an ambulatory care pharmacist, nurse practitioner, or a medical doctor, it is imperative that you contact them once you learn about your drug’s recall. Do not abruptly stop therapy without consulting your provider. Some medications pose severe risks if you suddenly stop taking them.

Your provider can work with you to develop a plan. Your pharmacy might be able to refill the medication from a different manufacturer that is not related to the recall. If they are not able to substitute with a different manufacturer, your provider will work with you to determine what is an appropriate alternative therapeutic regimen.

Step 3: Disposing of Your Medication

If your medication is recalled and your provider advises you to discontinue therapy and stop taking it, it is important to properly dispose of your medicine. The Drug Enforcement Agency (DEA) announces National Prescription Drug Take-Back events on their website. The FDA also has a website that shares useful tips on how to safely dispose of medicine.

 

Resources:

https://www.fda.gov/Drugs/DrugSafety/DrugRecalls/default.htm

https://www.deadiversion.usdoj.gov/drug_disposal/takeback/index.html

https://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm#1


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