# FDA recall D-1546-2022

> **Leading Pharma, LLC** · Class III · drug recall initiated 2022-08-23.

## Product

ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LEADING PHARMA, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-167-01

## Reason for recall

Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-1546-2022
- **Recalling firm:** Leading Pharma, LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-08-23
- **Report date:** 2022-10-05
- **Termination date:** 2023-09-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fairfield, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1546-2022

## Citation

> AI Analytics. FDA recall D-1546-2022. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/D-1546-2022. Source: US FDA. Licensed CC0.

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