Home / Recalls / Prinston Pharmaceutical Inc / D-0409-2019

D-0409-2019 Class II

Recalled by Prinston Pharmaceutical Inc — Somerset, NJ

Recall Details

Product Type
Drugs
Report Date
February 6, 2019
Initiation Date
January 18, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
19800 bottles

Product Description

Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhejiang 317024 China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-376-09

Reason for Recall

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Distribution Pattern

Nationwide

Code Information

331B18009

Other recalls by Prinston Pharmaceutical Inc

  • 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-0410-2019 Class II — Irbesartan and HydrochlorothiazideTablets, USP 150/12.5 mg Rx Only 90 count (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-0976-2018 Class II — Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tablets (July 13, 2018)
  • 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)