FDA recall D-1252-2019

Johnson Matthey Inc. · Class III · drug

Product

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.

Reason for recall

Failed Impurities/Degradation Specifications: Unknown impurity above specification limits.

Distribution

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.

Key facts

Status
Terminated
Initiation date
2019-04-02
Report date
2019-04-24
Termination date
2020-01-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
West Deptford, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1252-2019