Remifentanil HCl active pharmaceutical ingredient — Class III drug recall D-1252-2019
Terminated recall by Johnson Matthey Inc., reported 2019-04-24, distributed nationwide. Failed Impurities/Degradation Specifications: Unknown impurity above specification limits.
| Recall number | D-1252-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Johnson Matthey Inc., West Deptford, NJ, United States |
| Recall initiated | 2019-04-02 |
| Classified | 2019-04-30 |
| Reported by FDA | 2019-04-24 |
| Terminated | 2020-01-10 |
| Distributed | Nationwide (US) |
| Quantity | 416.95 g |
| Reason classes | specification failure |
| Lot numbers | B1319-170101 |
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 for recall
Failed Impurities/Degradation Specifications: Unknown impurity above specification limits.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1252-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.