FDAFDA · Food and drugs·Recall number D-1252-2019
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.
Published April 24, 2019 · Recall initiated: April 2, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: Unknown impurity above specification limits.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Johnson Matthey Inc.
- Distributor
- 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.
- Lot
- Lot #: B1319-170101
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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