Johnson Matthey Inc. recalls Remifentanil HCl active pharmaceutical ingredient (API) for manufacturing, processing or repackaging, 416.95 g glass con
Recalled April 24, 2019 · FDA recall D-1252-2019 · Johnson Matthey
Hazard
Failed Impurities/Degradation Specifications: Unknown impurity above specification limits. · FDA Class III
Units
416.95 g glass container
Sold at
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.
Description
Failed Impurities/Degradation Specifications: Unknown impurity above specification limits.
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.
Manufacturer(s)
Johnson Matthey Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →