As previously communicated, the FDA has been monitoring the supply chain with the expectation that the COVID-19 outbreak would likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S.
A manufacturer has alerted the FDA to a shortage of a drug that was recently added to the drug shortages list. The manufacturer just notified the FDA that this shortage is related to a site affected by coronavirus. The shortage is due to an issue with manufacturing of an active pharmaceutical ingredient (API) used in the drug.