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