# FDA recall D-1077-2019

> **Johnson Matthey Inc.** · Class II · drug recall initiated 2018-03-05.

## Product

Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742

## Reason for recall

Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API.

## Distribution

Nationwide in the US

## Key facts

- **Recall number:** D-1077-2019
- **Recalling firm:** Johnson Matthey Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-03-05
- **Report date:** 2019-04-10
- **Termination date:** 2021-07-23

- **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-1077-2019

## Citation

> AI Analytics. FDA recall D-1077-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-1077-2019. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*