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 Number: D-1252-2019

Firm: Johnson Matthey Inc.

Classification: Class III

Status: Terminated

Report Date: 20190424

Initiation Date: 20190402

Termination Date: 20200110

Reason for Recall

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

Product Description

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.