17/18 November 2020
Since July 2018, the FDA´s Enforcement Report weekly tracks and displays updates to a recall’s classification, reason for recall, code information, and product description if changes occur after initial publication.
In the FDA´s Enforcement Report all recalls monitored by the authority are included once they are classified. They may be listed prior to classification when the FDA determines the company’s removal or correction of a marketed product meets the definition of a recall. Once the FDA completes the hazard assessment, the Enforcement Report entry will be updated with the recall classification.
The FDA classifies a particular product recall to indicate the relative degree of health hazard (class I, II, or III) presented by the product being recalled. Recalls are categorized in the agency´s Enforcement Report as either class I, II, or III or "not yet classified."
FDA´s recall reports for July 2019 lists several Class II recalls due to various cGMP deviations including
Class III recalls in July 2019 were due to
Two of the recalls on the July 2019 listings have been categorized as Class I (serious health risk). Both of these were injectables:
For more information about FDA-regulated products recalls, you can visit Recalls, Market Withdrawals, & Safety Alerts.