# FDA recall D-0652-2021

> **The Harvard Drug Group** · Class II · drug recall initiated 2021-07-02.

## Product

NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 count unit dose carton, NDC 0904-7080-61; b) 50 count unit dose carton, NDC 0904-7080-06: Distributed by: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408  Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 USA

## Reason for recall

Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.

## Distribution

Distributed in OH and NJ

## Key facts

- **Recall number:** D-0652-2021
- **Recalling firm:** The Harvard Drug Group
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-07-02
- **Report date:** 2021-07-21
- **Termination date:** 2022-12-28

- **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-0652-2021

## Citation

> AI Analytics. FDA recall D-0652-2021. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/D-0652-2021. Source: US FDA. Licensed CC0.

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