# FDA recall D-1658-2012

> **VistaPharm, Inc.** · Class II · drug recall initiated 2011-04-06.

## Product

Xactdose Phenytoin Oral Suspension, USP, 125mg/ 5 mL, supplied in 5 mL unit dose cups, Manufactured by VistaPharm, Inc., Largo, FL --- NDC 66689-035-50

## Reason for recall

Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1658-2012
- **Recalling firm:** VistaPharm, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2011-04-06
- **Report date:** 2012-08-29
- **Termination date:** 2012-11-23

- **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-1658-2012

## Citation

> AI Analytics. FDA recall D-1658-2012. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-1658-2012. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*