Remifentanil HCl active pharmaceutical ingredient recall: Impurity Out of Spec
Remifentanil HCl active pharmaceutical ingredient (API) for manufacturing, processing or repackaging, 416.95 g glass container, Rx ONLY, Johnson…
Why was Remifentanil HCl active pharmaceutical ingredient recalled?
Failed Impurities/Degradation Specifications: Unknown impurity above specification limits.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: B1319-170101
- Product
- Remifentanil HCl active pharmaceutical ingredient (API) for manufacturing, processing or repackaging, 416.95 g glass container, Rx ONLY, Johnson…
- Recalling firm
- Johnson Matthey Inc.
- Quantity
- 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.
- Recall date
- April 24, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)