# FDA recall D-0649-2022

> **The Harvard Drug Group** · Class II · drug recall initiated 2022-02-28.

## Product

PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, India. Distributed by: MAJOR PHARMACEUTICALS, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. NDC: 0904-6937-61

## Reason for recall

Failed Dissolution Specifications

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0649-2022
- **Recalling firm:** The Harvard Drug Group
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-02-28
- **Report date:** 2022-03-16
- **Termination date:** 2023-06-08

- **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-0649-2022

## Citation

> AI Analytics. FDA recall D-0649-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0649-2022. Source: US FDA. Licensed CC0.

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