Telmisartan and Hyrdochlorothiazide Tablets, USP 80mg/12.5 mg, 30-coun bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Imachal Pradesh, India NDC 33342-129-07

Reason: Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.

Code information: Lot #: BTM703A, BTM704A, BTM706A, BTM707A, Exp Feb-19; TM708A,BTM709A, Exp Apr-19; BTM710A, Exp Jun-19; BTM711A, BTM712A, Exp Oct-19; BTM713A,BTM714A, BTM715A, Exp Nov-19; BTM801A, BTM802A, BTM803A, BTM804A, Exp Dec-19; BTM806A,BTM807A, Exp Mar-20; BTM809A Exp Apr-20; BTM810A, BTM811A, BTM812A, Exp. Jul-20; BTM813A, BTM814A, BTM815A, BTM816A, BTM817A, Exp Sep-20; BTM818A, BTM819A Exp Nov-20.

Distribution pattern: Nationwide within the United States