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.
Reported: April 24, 2019 Initiated: April 2, 2019 #D-1252-2019
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.
Reason for Recall
Failed Impurities/Degradation Specifications: Unknown impurity above specification limits.
Details
- Recalling Firm
- Johnson Matthey Inc.
- Units Affected
- 416.95 g glass container
- 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.
- Location
- West Deptford, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Johnson Matthey Inc.. Units affected: 416.95 g glass container.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Unknown impurity above specification limits.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 24, 2019. Severity: Low. Recall number: D-1252-2019.
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