Reported Apr 24, 2019 · Terminated
Remifentanil HCl active pharmaceutical ingredient (API) for manufacturing, processing or repackaging, 416.95 g glass…
Johnson Matthey Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Johnson Matthey Inc. · 2003 Nolte Dr · West Deptford, NJ · 08066-1727
Is this the product you have?
- 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.
- Lot codes and dates
- Lot #: B1319-170101
- Amount recalled
- 416.95 g glass container
Where it was sold
- Nationwide
- WV
Why it was recalled
Failed Impurities/Degradation Specifications: Unknown impurity above specification limits.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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