# FDA recall D-0018-2023

> **VistaPharm, Inc.** · Class II · drug recall initiated 2022-09-30.

## Product

Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Dist. by: VistaPharm, NDC 66689-406-01

## Reason for recall

cGMP Deviations: Out of specification for assay of one of the preservative ingredients.

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0018-2023
- **Recalling firm:** VistaPharm, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-09-30
- **Report date:** 2022-11-02
- **Termination date:** 2024-04-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Largo, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0018-2023

## Citation

> AI Analytics. FDA recall D-0018-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0018-2023. Source: US FDA. Licensed CC0.

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