FDA recall D-0829-2020

Product

Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, 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/Degredation Specifications: This recall is initiated as a precautionary measure due to potential migration of Benzophenone at very low level into product from container label.

Distribution

Distributed Nationwide in the US

Key facts

Status

Terminated

Initiation date

2020-01-29

Report date

2020-02-12

Termination date

2021-01-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Brunswick, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0829-2020