UNICHEM PHARMACEUTICALS USA INC recalls Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufactured by: Unichem Laboratories LTD. Piler
Recalled June 17, 2020 · FDA recall D-1291-2020 · UNICHEM PHARMACEUTICALS USA
Hazard
Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container. · FDA Class III
Units
190,992 bottles
Sold at
Nationwide within the United States
Description
Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
Product
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
Manufacturer(s)
UNICHEM PHARMACEUTICALS USA INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →