# FDA recall D-0878-2022

> **Monarch PCM, LLC** · Class III · drug recall initiated 2022-04-14.

## Product

Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles,  Rx Only,  Manufactured for: Westminster Pharmaceuticals, LLC Tampa, FL 33624, NDC 69367-172-16

## Reason for recall

Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content

## Distribution

TN only

## Key facts

- **Recall number:** D-0878-2022
- **Recalling firm:** Monarch PCM, LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-04-14
- **Report date:** 2022-05-25
- **Termination date:** 2023-06-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fort Worth, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0878-2022

## Citation

> AI Analytics. FDA recall D-0878-2022. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/D-0878-2022. Source: US FDA. Licensed CC0.

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