FDA-Drug2020-06-17Class III
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
UNICHEM PHARMACEUTICALS USA INC
Hazard
Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
Sold states
Nationwide within the United States
Affected count
190,992 bottles
Manufactured in
1 Tower Center Blvd Ste 2200, N/A, East Brunswick, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1291-2020Don't want to check this manually?
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