# FDA recall D-0807-2021

> **The Harvard Drug Group** · Class II · drug recall initiated 2021-08-06.

## Product

Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd., Bharuch-392130, India; Manufactured for: Torrent Pharma, Inc., Basking Ridge, NJ 07920; Distributed by: MAJOR PHARMACEUTICALS, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA.  NDC 0904-6172-61

## Reason for recall

Failed Dissolution Specifications

## Distribution

NC

## Key facts

- **Recall number:** D-0807-2021
- **Recalling firm:** The Harvard Drug Group
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-08-06
- **Report date:** 2021-09-29
- **Termination date:** 2022-11-08

- **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-0807-2021

## Citation

> AI Analytics. FDA recall D-0807-2021. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0807-2021. Source: US FDA. Licensed CC0.

---

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