# FDA recall D-0824-2020

> **Pharmaceutical Associates Inc** · Class II · drug recall initiated 2020-01-14.

## Product

Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL)  Rx Only, pai, Pharmaceutical Associates, Inc. Greenville, SC 29605. NDC 0121-0810-16

## Reason for recall

Subpotent: Out of specification for assay at the 12-month time point.

## Distribution

Distributed Nationwide in the US

## Key facts

- **Recall number:** D-0824-2020
- **Recalling firm:** Pharmaceutical Associates Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-01-14
- **Report date:** 2020-02-05
- **Termination date:** 2021-06-03

- **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-0824-2020

## Citation

> AI Analytics. FDA recall D-0824-2020. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0824-2020. Source: US FDA. Licensed CC0.

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