Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg, (a) 30-count bottle...
FDA Recall #D-0307-2019 — Class II — November 27, 2018
Product Description
Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7807-56) & 90-count bottles (NDC 0093-7807-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
Reason for Recall
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
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
41,572 bottles
Distribution
USA Nationwide including Puerto Rico.
Code Information
NDC 0093-7807-56 & 0093-7807-98 Lot # 18X010, 18X011
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated