Home / Recalls / Avkare Incorporated / D-1176-2018

D-1176-2018 Class II Terminated

Recalled by Avkare Incorporated — Pulaski, TN

Recall Details

Product Type
Drugs
Report Date
September 12, 2018
Initiation Date
July 18, 2018
Termination Date
May 7, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12950 bottles

Product Description

AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-886-90

Reason for Recall

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Distribution Pattern

Nationwide

Code Information

Lots: 17780 Exp. 09/2018; 18029 Exp. 09/2018; 18398 Exp. 09/2018; 18723 Exp. 09/2018; 19017 Exp. 02/2019; 19224 Exp. 02/2019; 20032 Exp. 08/2019; 20289 Exp. 08/2019; 21076 Exp. 08/2019; 21382 Exp. 08/2019

Other recalls by Avkare Incorporated

  • D-1177-2018 Class II — AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle, R (July 18, 2018)
  • D-1173-2018 Class II — AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bottle, (July 18, 2018)
  • D-1175-2018 Class II — AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets, 90-count bottle, (July 18, 2018)
  • D-1174-2018 Class II — AvKARE Valsartan and Hydrochlorothiazide 160 mg/12.5 mg tablets, 90-count bottle (July 18, 2018)