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

Recall Number: D-1291-2020

Firm: UNICHEM PHARMACEUTICALS USA INC

Classification: Class III

Status: Terminated

Report Date: 20200617

Initiation Date: 20200526

Termination Date: 20210108

Reason for Recall

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

Product Description

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