Remifentanil HCl active pharmaceutical ingredient (API) for manufacturing, processing or repackaging, 416.95 g glass container, Rx ONLY, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742.

Recall Insight

This FDA Drug action (record #D-1252-2019) was formally reported on April 24, 2019, with the manufacturer initiating the action on April 2, 2019. It is classified under Low severity (Class III), with a current status of Terminated. Johnson Matthey Inc. is listed as the recalling firm, operating out of West Deptford, NJ. Federal records indicate 416.95 g glass container units are affected.

The documented reason for this recall is: Failed Impurities/Degradation Specifications: Unknown impurity above specification limits. Distribution data in the federal record shows the product reached: Product was distributed to one manufacturer in Morgantown, WV who may have manufactured the product into finished product and further distribute to the retail level Nationwide in the USA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 5 were also issued by FDA Drug. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 7 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.