UNICHEM PHARMACEUTICALS USA INC recalls Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufactured by: Unichem Laboratories Ltd. Piler…

Recall date

January 29, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0829-2020

FDA classification

Class III

Brand / firm

UNICHEM PHARMACEUTICALS USA INC

Sold / distributed

Distributed Nationwide in the US

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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