# FDA recall D-0015-2021

> **PAI Holdings, LLC. dba Pharmaceutical Associates Inc** · Class III · drug recall initiated 2020-09-09.

## Product

Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg for: Pharmaceutical Associates, Inc. Greenville, SC 29605 NDC 0121-1696-40

## Reason for recall

Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-0015-2021
- **Recalling firm:** PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-09-09
- **Report date:** 2020-10-14
- **Termination date:** 2022-02-22

- **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-0015-2021

## Citation

> AI Analytics. FDA recall D-0015-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/D-0015-2021. Source: US FDA. Licensed CC0.

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