# FDA recall D-0854-2021

> **American Health Packaging** · Class II · drug recall initiated 2021-09-15.

## Product

Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 Case NDC#: 60687-262-56; Individual Dose NDC: 60687-262-42

## Reason for recall

CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.

## Distribution

Nationwide USA

## Key facts

- **Recall number:** D-0854-2021
- **Recalling firm:** American Health Packaging
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-09-15
- **Report date:** 2021-10-06
- **Termination date:** 2023-06-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Columbus, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0854-2021

## Citation

> AI Analytics. FDA recall D-0854-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0854-2021. Source: US FDA. Licensed CC0.

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