FDA-Drug2020-02-12Class III

Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, 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/Degredation Specifications: This recall is initiated as a precautionary measure due to potential migration of Benzophenone at very low level into product from container label.

Sold states
Distributed Nationwide in the US
Affected count
19161600 units
Manufactured in
1 Tower Center Blvd Ste 2200, N/A, East Brunswick, NJ, United States
Products
Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, 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-0829-2020

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