FDA Drug recall D-1252-2019
Remifentanil HCl active pharmaceutical ingredient (API) for manufacturing, processing or repackaging, 416.95 g glass container, Rx ONLY, Jo…
- FDA Drug
- Class III
- terminated
- Published 2019-04-24
On 2019-04-24 the FDA classified a Class III recall of Remifentanil HCl active pharmaceutical ingredient (API) for manufacturing, processing or repackaging, 416.95 g glass container, Rx ONLY, Jo… by Johnson Matthey, citing failed Impurities/Degradation Specifications: Unknown impurity above specification limits.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1252-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-04-02 |
| Published | 2019-04-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Johnson Matthey |
| Distribution | US |
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.
Reason
Failed Impurities/Degradation Specifications: Unknown impurity above specification limits.
Identifiers
| code_info | Lot #: B1319-170101 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1252-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.