# FDA recall D-1291-2020

> **UNICHEM PHARMACEUTICALS USA INC** · Class III · drug recall initiated 2020-05-26.

## Product

Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, 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 29300-135-01

## Reason for recall

Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-1291-2020
- **Recalling firm:** UNICHEM PHARMACEUTICALS USA INC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-05-26
- **Report date:** 2020-06-17
- **Termination date:** 2021-01-08

- **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-1291-2020

## Citation

> AI Analytics. FDA recall D-1291-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1291-2020. Source: US FDA. Licensed CC0.

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