# FDA recall D-1060-2020

> **PAI Holdings, LLC. dba Pharmaceutical Associates Inc** · Class II · drug recall initiated 2020-03-19.

## Product

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

## Reason for recall

SubPotent Drug: Low out-of-specification results for assay testing.

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-1060-2020
- **Recalling firm:** PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-03-19
- **Report date:** 2020-04-01
- **Termination date:** 2021-09-22

- **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-1060-2020

## Citation

> AI Analytics. FDA recall D-1060-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1060-2020. Source: US FDA. Licensed CC0.

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