Home / Recalls / Prinston Pharmaceutical Inc / D-0972-2018

D-0972-2018 Class II Ongoing

Recalled by Prinston Pharmaceutical Inc — Cranbury, NJ

Recall Details

Product Type
Drugs
Report Date
August 1, 2018
Initiation Date
July 13, 2018
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 80 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-311-09

Reason for Recall

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

Distribution Pattern

United States

Code Information

All lots within expiry.

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-0411-2019 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-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)