Learning about the announcement of a drug recall, or product recall of any kind, can be a disheartening notice to receive. No matter the drug, product, or situation, receiving notice of a recall can immediately sound internal alarm bells for patients and health professionals alike.
Often, general news about the announcement of a recall can spread via media outlets, word of mouth, through a direct update by a pharmacy, etc. However, it is common to not receive any specific details about a recall and what it may specifically consist of. This lack of detail typically leads to questions and concerns.
To learn more about a recall, the United States Food & Drug Administration (FDA) is the bona fide resource to utilize.
There are 3 main types of recalls – Class I, Class II, and Class III. A Class I recall is the most serious type of recall whereas a Class III recall is the least serious. Per the FDA, each recall is described as:
- Class I: Dangerous or defective products that predictably could cause serious health problems or death.
- Class II: Products that might cause a temporary health problem, or pose only a slight threat of a serious nature.
- Class III: Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws.
Many items (human drugs, animal drugs, medical devices, radiation-emitting products, vaccines, blood and blood products, transplantable human tissue, animal feed, cosmetics, and about 80 percent of the foods eaten in the United States) are subject to be recalled by the FDA as needed. This article will specifically focus on drug recalls.
To learn more about obtaining details of a drug recall, follow the steps outlined below. After these steps are described, a hypothetical example scenario is described.
2. Access the FDA’s Drug Recall Website
First and foremost, the FDA’s Drug Recalls website should be accessed and it is accessible here. Without easy access to the website link, the website can also be referenced by going to a search engine of choice and typing “FDA Drug Recalls” (or similar).
For reference, the page is shown in the above image.
2. Utilize the Search Function
If a user scrolls down to the middle section of the FDA’s Drug Recalls page, the portion of the page shown in the image above can be seen. To search for a drug, simply type in the name of the drug in the search field.
Drug recalls are typically specific to a certain drug of a specific manufacturer. So, searches need to be relevant to that criteria.
For example, if an individual learned that their metformin ER 500 mg tablets were recalled and they typed in “metformin” as a search term, proper result options should appear in the table. But, if that person instead typed in “Glucophage” (the brand name of metformin), nothing and/or improper results would appear if the product that was dispensed to the individual was a generic metformin product.
If you perform a search, correctly type the name of the drug, and nothing pops up, the drug likely is not under a recall.
3. Alternatively, Search by Product Type
From the main FDA Drug Recalls page, select the link shown below that is highlighted in yellow.
After you click on that link, scroll down to the middle of the page. Look for the small box titled “Filters”. If the drop down arrow beneath the heading of “Product Type is clicked (see image below), you can narrow down drugs to sift through by category.
The categories that can be selected are “Animal & Veterinary” products, “Biologic” products, “Cosmetic” products, “Dietary Supplements”, and “Drugs”. Furthermore, if desired, users can select a category and also search by a keyword or a portion of a word.
On this same webpage, there is a button that says “Export Excel”. If that button is selected, all of the data that is being displayed in the table under the search bar will be exported to a Microsoft Excel spreadsheet. The data provided in the spreadsheet details the initial recall notice date, name of the manufacturer, description of the product, product type, recall reason description, and company name.
4. Select the Proper Drug Listing to Learn Recall Details
Like prior mentioned, as recall notices are specific to both a drug and its manufacturer, the proper drug needs to be selected along with the correct manufacturer in the data table.
Information about the recall is summarized in the data table provided on the main page of the search listings. However, for more information, click on the blue text highlighted in the “Brand Name(s)” column, shown above. This blue text is a hyperlink to specific details about the recall.
For example, if someone was taking valsartan and they were dispensed valsartan tablets produced by Camber Pharmaceuticals, they may click on the blue link within the second line of the data table above to learn details about their recalled valsartan tablets.
Example Scenario
A patient, Adrian, receives a text message from his pharmacy stating that his medication beginning with the letters “MET” has been recalled. Being a patient who is on top of knowing what medicines he is taking, he immediately knows this is referring to his prescription for metformin ER 500 mg tablets. However, Adrian receives no other details in the text message. As time goes on, Adrian becomes worried about the details of the recall and how it may affect him, given his notice about it was vague and seemingly incomplete.
Adrian tries to call his pharmacy about the text message to learn more information about the recall, but the pharmacy seems very busy and Adrian doesn’t have time at the moment to wait for them to answer. So, he looks at the label of the vial given to him by his pharmacy and notices that “Actavis” is the manufacturer of the metformin ER 500 mg tablets he was dispensed.
With this information in mind, Adrian pulls up the FDA Drug Recalls webpage and types in the word “metformin” in the page’s search bar. In the table that populates data based on his search term, he notices that Actavis is the option on the 5th results row of the table. He quickly noticed the “Recall Reason Description” is due to the detection of NDMA (a potential carcinogen).
However, Adrian wants to learn even more about the recall. He clicks on the hyperlink within the data table to the Actavis link, and the resultant page (shown below) loads with full details about the recall. By reading through the page below and continuing to scroll down, Adrian learns the full details currently available about the recall. Based on what he reads, he can then contact his pharmacist or other healthcare provider inquiring about next steps.
References:
- Recalls, Market Withdrawals, & Safety Alerts. United States Food & Drug Administration. Accessed 14 July 2020.
- Recalls Background and Definition. United States Food & Drug Administration. Accessed 14 July 2020.
- FDA 101: Product Recalls. United States Food & Drug Administration. Accessed 14 July 2020.
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