# FDA recall D-1204-2018

> **Torrent Pharma Inc.** · Class II · drug recall initiated 2018-09-11.

## Product

Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920. NDC: 13668-342-30

## Reason for recall

Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.

## Distribution

Nationwide USA

## Key facts

- **Recall number:** D-1204-2018
- **Recalling firm:** Torrent Pharma Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-09-11
- **Report date:** 2018-09-26
- **Termination date:** 2020-09-04

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1204-2018

## Citation

> AI Analytics. FDA recall D-1204-2018. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/D-1204-2018. Source: US FDA. Licensed CC0.

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