# FDA recall D-0597-2016

> **Pharmakon Pharmaceuticals** · Class II · drug recall initiated 2015-08-19.

## Product

Morphine Sulfate (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

## Reason for recall

Stability data does not support expiry.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0597-2016
- **Recalling firm:** Pharmakon Pharmaceuticals
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-08-19
- **Report date:** 2016-02-03
- **Termination date:** 2017-05-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Noblesville, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0597-2016

## Citation

> AI Analytics. FDA recall D-0597-2016. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0597-2016. Source: US FDA. Licensed CC0.

---

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