# FDA recall D-0865-2018

> **Pharmaceutical Associates Inc** · Class III · drug recall initiated 2018-05-29.

## Product

Nystatin Oral Suspension,  USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-4810-05

## Reason for recall

Resuspension problems: Out of specification for appearance and resuspendability.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0865-2018
- **Recalling firm:** Pharmaceutical Associates Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-05-29
- **Report date:** 2018-06-13
- **Termination date:** 2020-01-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Greenville, SC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0865-2018

## Citation

> AI Analytics. FDA recall D-0865-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0865-2018. Source: US FDA. Licensed CC0.

---

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