FDA-Drug2019-04-24Class III
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.
Johnson Matthey Inc.
Hazard
Failed Impurities/Degradation Specifications: Unknown impurity above specification limits.
Sold states
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.
Affected count
416.95 g glass container
Manufactured in
2003 Nolte Dr, N/A, West Deptford, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1252-2019Don't want to check this manually?
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