Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP, 7.5 mg/12.5 mg, 100-count bottle, R...
FDA Recall #D-0208-2018 — Class II — December 14, 2017
Product Description
Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP, 7.5 mg/12.5 mg, 100-count bottle, Rx only, Distributed By: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5213-01.
Reason for Recall
Failed Impurities/Degradation Specifications: High out of specification test result for the Moexipril Diketopiperazine impurity was obtained during routine stability testing.
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
4,969 bottles
Distribution
Nationwide in the USA
Code Information
Lot # 30229439A, Exp 12/17
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated