# FDA recall D-0806-2021

> **The Harvard Drug Group** · Class II · drug recall initiated 2021-07-29.

## Product

Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152.  NDC 0904-6822-04

## Reason for recall

Failed Dissolution Specifications

## Distribution

CO, FL, MO, OH

## Key facts

- **Recall number:** D-0806-2021
- **Recalling firm:** The Harvard Drug Group
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-07-29
- **Report date:** 2021-09-29
- **Termination date:** 2023-02-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Livonia, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0806-2021

## Citation

> AI Analytics. FDA recall D-0806-2021. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0806-2021. Source: US FDA. Licensed CC0.

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