Johnson Matthey Recalls Remifentanil HCl API Due to Impurity Issues
Johnson Matthey Inc. is recalling Remifentanil HCl active pharmaceutical ingredient (API) because an unknown impurity exceeded specification limits.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Johnson Matthey Inc. is recalling Remifentanil HCl active pharmaceutical ingredient (API) in 416.95 g glass containers. The recall is due to failed impurities and degradation specifications, specifically the presence of an unknown impurity above specification limits.
The affected product is Lot B1319-170101. This API is intended for manufacturing, processing, or repackaging and is marked Rx ONLY. The product was distributed to one manufacturer in Morgantown, WV, who may have used it to manufacture finished products for nationwide distribution in the USA.
Consumers should note that this recall involves raw pharmaceutical ingredients rather than finished consumer medications. Individuals who have purchased finished products containing this API should contact their healthcare provider or pharmacist for guidance. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- 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.
- Manufacturer
- Johnson Matthey Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #: B1319-170101
Distribution
Distributed nationwide across the United States.
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