# FDA recall D-1252-2019

> **Johnson Matthey Inc.** · Class III · drug recall initiated 2019-04-02.

## 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.

## 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.

## Key facts

- **Recall number:** D-1252-2019
- **Recalling firm:** Johnson Matthey Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-04-02
- **Report date:** 2019-04-24
- **Termination date:** 2020-01-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** West Deptford, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1252-2019

## Citation

> AI Analytics. FDA recall D-1252-2019. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/D-1252-2019. Source: US FDA. Licensed CC0.

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