Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg, packaged in a) 30-count bottle...
FDA Recall #D-0381-2019 — Class II — December 19, 2018
Product Description
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
Reason for Recall
Failed dissolution specifications
Recalling Firm
Teva Pharmaceuticals USA — North Wales, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
181,456 bottles
Distribution
U.S.A. nationwide
Code Information
Lot #: a) 49O005, 49O006, 49O007, 49O010, Exp 02/2019; b) 49O005, 49O009, 49O010, Exp 02/2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated