# FDA recall D-342-2014

> **VistaPharm, Inc.** · Class II · drug recall initiated 2013-10-15.

## Product

Phenytoin Oral Suspension USP 125mg/5mL,  50 cups per case, For Oral Administration Only, Rx Only, Manufactured by: VistaPharm Inc, Largo, FL 33771, NDC 66689-036-50

## Reason for recall

Defective Container: A lidding deformity allowed for the product to have out of specification results for assay and viscosity at the12 month stability timepoint.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-342-2014
- **Recalling firm:** VistaPharm, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-10-15
- **Report date:** 2013-12-18
- **Termination date:** 2016-09-28

- **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-342-2014

## Citation

> AI Analytics. FDA recall D-342-2014. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-342-2014. Source: US FDA. Licensed CC0.

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