UNICHEM PHARMACEUTICALS USA INC recalls Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufactured by: Unichem Laboratories LTD. Pile…

Recall date

May 26, 2020

Source

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

Recall number

D-1291-2020

FDA classification

Class III

Brand / firm

UNICHEM PHARMACEUTICALS USA INC

Sold / distributed

Nationwide within the United States

Why it was recalled

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

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

What was recalled

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