Definitions
A voluntary action that takes place because a product presents a risk of injury or gross deception or is otherwise defective
It is required to report a correction or removal initiative to the FDA within this number of days
10 DAYS
A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
CLASS I RECALL
This supplement was recalled in February 2024 due to a manufacturing error that produced the following side effects: Elevated vitamin D levels, vomiting, and loss of appetite.
VITAMIN D3
MedWatch receives reports from the public, and when appropriate publishes safety alerts for FDA-regulated products. FDA-regulated products include prescription and OTC medications, biologics, medical devices, special nutrition products, cosmetics, and one final category. What is the final category?
FOOD
The physical removal of a device from its point of use to some other location for repair, modification, adjustment, relabeling, destruction, or inspection.
REMOVAL
FDA electronic submission software (eSubmitter) or email are the two methods of contact used for what aspect of an FDA recall?
REPORTING OR ALERTING THE FDA
A situation in which the use of, or exposure to, a violative product is not likely to cause adverse health consequences
CLASS III RECALL
This common antiplatelet therapy was recalled in 2018 due to a labeling error that replaced simvastatin with the intended drug, resulting in an increased risk of acute MI and stroke.
FDA recalls are considered to be what type of action
VOLUNTARY
Repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location.
CORRECTION
When the FDA determines that all reasonable efforts have been made to remove or correct the product by the recall strategy, and when it is reasonable to assume that the product subject to the recall has been removed and proper disposition or correction has been made
TERMINATION OF A RECALL
After proper notification to the manufacturer or importer by the FDA, if the manufacturer or importer fails to voluntarily recall a device that has been found with a reasonable probability to cause serious adverse health consequences or death, the FDA may initiate this type of recall
MANDATORY RECALL
This popular oral rinse, used for the treatment of gingivitis, was recalled in 2020 due to microbial contamination.
CHLORHEXIDINE GLUCONATE (PERIDEX)
The FDA utilizes a social media app to release current FDA recall information to the public.
A 2017 FDA initiative aimed at increasing transparency and promoting public health. The FDA has determined that a firm’s action meets the definition of a recall however the FDA has not completed its assessment of the hazard posed by the recalled product.
PENDING CLASSIFICATION
Following the submission of a report, a manufacturer or importer decides to extend a correction or removal to additional lots or batches of the same device.
AMENDMENT
A situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
CLASS II RECALL
This popular food chain agreed to pay a 25 million dollar fine in response to over 1,100 people reporting food-borne illnesses between the years of 2015-2018
CHIPOTLE
The Division of Industry and Consumer Education Center for Devices and Radiological Health Food and Drug Administration is located in a state famous for blue crabs.
The Enforcement Report monitors and presents modifications to a recall's Classification, Reason for Recall, Code Information, and Product Description in the event of changes following the initial publication. This feature is accessible for all recalls posted or updated from July 24, 2018, onward. Details on how these changes are presented and which sections of the Enforcement Report are impacted can be found on what page?
ENFORCEMENT REPORT HISTORY FEATURE PAGE
This person/group of people is required to report a correction or removal of a product if it involves a risk to health
MANUFACTURER OR IMPORTER
A recall is a voluntary process that may be initiated at the manufacturer’s discretion at any time without the request of the FDA and does not include market withdrawal or a stock recovery
This top drug and vaccine manufacturer recalled five lots of Accupril tablets in 2022.
PFIZER
This weekly report contains all enforcement actions including recalls, field corrections, seizures, and injunctions.
FDA ENFORCEMENT REPORT