Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg, packaged in a) 30-count bottle (NDC 0093-7617-56), b) 90-count bottle (NDC 0093-7617-98), Rx only, Manufactured In Israel By: Teva Pharmaceutical, IND. LTD., Jerusalem, 9777402, Israel, Manufactured For: Teva Pharmaceutical USA, INC., North Wales, PA 19454

Recall Number: D-0381-2019

Firm: Teva Pharmaceuticals USA

Classification: Class II

Status: Terminated

Report Date: 20190123

Initiation Date: 20181219

Termination Date: 20200831

Failed dissolution specifications

Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg, packaged in a) 30-count bottle (NDC 0093-7617-56), b) 90-count bottle (NDC 0093-7617-98), Rx only, Manufactured In Israel By: Teva Pharmaceutical, IND. LTD., Jerusalem, 9777402, Israel, Manufactured For: Teva Pharmaceutical USA, INC., North Wales, PA 19454