Teva Pharmaceuticals USA recalls Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg, packaged in a) 30-count bottle (NDC 0093-7617-56), b…

Recall date

December 19, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0381-2019

FDA classification

Class II

Brand / firm

Teva Pharmaceuticals USA

Sold / distributed

U.S.A. nationwide

Why it was recalled

Failed dissolution specifications

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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