Home / Recalls / Prinston Pharmaceutical Inc / D-0209-2018

D-0209-2018 Class II Terminated

Recalled by Prinston Pharmaceutical Inc — Cranbury, NJ

Recall Details

Product Type
Drugs
Report Date
January 17, 2018
Initiation Date
November 29, 2017
Termination Date
August 16, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
21,987 bottles

Product Description

Valsartan Tablets, USP, 160 mg, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, China; Distributed by: Solco Healthcare US, LLC, Cranbury, NJ 08512, USA; NDC 43547-369-09.

Reason for Recall

Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.

Distribution Pattern

Nationwide in the USA and Puerto Rico

Code Information

Lot #: 343B17025, Exp 03/31/19

Other recalls by Prinston Pharmaceutical Inc

  • D-0410-2019 Class II — Irbesartan and HydrochlorothiazideTablets, USP 150/12.5 mg Rx Only 90 count (January 18, 2019)
  • D-0412-2019 Class II — Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured (January 18, 2019)
  • D-0409-2019 Class II — Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huahai (January 18, 2019)
  • D-0413-2019 Class II — Irbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx 30 Tablets Only M (January 18, 2019)
  • D-0411-2019 Class II — Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured (January 18, 2019)
  • D-0973-2018 Class II — Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12.5 MG Table (July 13, 2018)
  • D-0970-2018 Class II — Solco Healthcare US Valsartan, USP, 160 MG Tablets, 90-count bottles, Rx Only Ma (July 13, 2018)
  • D-0974-2018 Class II — Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets (July 13, 2018)
  • D-0969-2018 Class II — Solco Healthcare US Valsartan, USP, 80 MG Tablets, 90-count bottle, Rx Only Manu (July 13, 2018)
  • D-0975-2018 Class II — Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/12.5 MG Table (July 13, 2018)