# FDA recall D-1541-2022

> **UNICHEM PHARMACEUTICALS USA INC** · Class III · drug recall initiated 2022-09-19.

## Product

Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC. East Brunswick, NJ 08816. NDC# 29300-137-01

## Reason for recall

Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-1541-2022
- **Recalling firm:** UNICHEM PHARMACEUTICALS USA INC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-09-19
- **Report date:** 2022-09-28
- **Termination date:** 2023-03-02

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1541-2022

## Citation

> AI Analytics. FDA recall D-1541-2022. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/D-1541-2022. Source: US FDA. Licensed CC0.

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