April 25, 2019
Johnson Matthey Inc. is recalling a single lot of remifentanil hydrochloride because of an unknown impurity that exceeded specification limits, according to the April 24, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall is for remifentanil hydrochloride active pharmaceutical ingredient (API) for manufacturing, processing, or repackaging, 416.95 g glass container, from lot B1319-170101.
The recalled remifentanil hydrochloride was distributed to a manufacturer in Morgantown, WV, that may have used the API in manufacturing and further distributed it at the retail level throughout the United States.
Johnson Matthey voluntarily issued the recall April 2, 2019. At press time, the FDA had not yet issued a recall designation.
Remifentanil hydrochloride is a prescription narcotic used to relieve pain during medical procedures.