Home / Recalls / Avkare Incorporated / D-1177-2018

D-1177-2018 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
19623 bottles

Product Description

AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-888-90

Reason for Recall

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

Distribution Pattern

Nationwide

Code Information

Lots: 17308 Exp. 09/2018; 18158 Exp. 09/2018; 18539 Exp. 01/2019; 19021 Exp. 01/2019; 19225 Exp. 01/2019; 20033 Exp. 06/2019; 20290 Exp. 06/2019; 20565 Exp. 06/2019; 21369 Exp. 10/2019

Other recalls by Avkare Incorporated

  • D-1173-2018 Class II — AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bottle, (July 18, 2018)
  • D-1176-2018 Class II — AvKARE Valsartan and Hydrochlorothiazide 320 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)