Why it was recalled
Failed Impurities/Degradation Specifications: Unknown impurity above specification limits.
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.
Lot numbers, UPCs & expiration codes
Lot #: B1319-170101
Where it was sold
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.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1252-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 2, 2019
- FDA report date
- Apr 24, 2019
- Quantity
- 416.95 g glass container
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Johnson Matthey Inc.
Original FDA data
Every field from FDA enforcement report D-1252-2019, exactly as published.
Show all FDA fields
- City
- West Deptford
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 82618
- Address
- 2003 Nolte Dr
- Code information
- Lot #: B1319-170101
- Postal code
- 08066-1727
- Report date
- Apr 24, 2019
- Product type
- Drugs
- Recall number
- D-1252-2019
- Classification
- Class III
- Recalling firm
- Johnson Matthey Inc.
- Product quantity
- 416.95 g glass container
- Termination date
- Jan 10, 2020
- Reason for recall
- Failed Impurities/Degradation Specifications: Unknown impurity above specification limits.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- 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 initiation date
- Apr 2, 2019
- Initial firm notification
- Center classification date
- Apr 30, 2019