Home / Brands / Prinston Pharmaceutical
Prinston Pharmaceutical Recalls
16 recalls on record · June 29, 2016 to February 6, 2019 · Drugs
Recalls by year
16
18
19
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 6, 2019DrugsFDA
Prinston Pharmaceutical Inc recalls Irbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx 30 Tablets Only Manufactured by: Zhejiang Huahai Pharmace
Hazard: 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.
February 6, 2019DrugsFDA
Prinston Pharmaceutical Inc recalls Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co.,
Hazard: 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.
February 6, 2019DrugsFDA
Prinston Pharmaceutical Inc recalls Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co.,
Hazard: 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.
February 6, 2019DrugsFDA
Prinston Pharmaceutical Inc recalls Irbesartan and HydrochlorothiazideTablets, USP 150/12.5 mg Rx Only 90 count Manufactured by: Zhejiang Huahai Pharmac
Hazard: 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.
February 6, 2019DrugsFDA
Prinston Pharmaceutical Inc recalls Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhe
Hazard: 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.
August 1, 2018DrugsFDA
Prinston Pharmaceutical Inc recalls Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tablets, 90-count bottles, Rx Only, Manufacture
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 1, 2018DrugsFDA
Prinston Pharmaceutical Inc recalls Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/12.5 MG Tablets, 90-count bottle, Rx Only, Manufactur
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 1, 2018DrugsFDA
Prinston Pharmaceutical Inc recalls Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets, 90-count bottle, Rx Only, Manufactured
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 1, 2018DrugsFDA
Prinston Pharmaceutical Inc recalls Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufactu
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 1, 2018DrugsFDA
Prinston Pharmaceutical Inc recalls Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 80 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufactur
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 1, 2018DrugsFDA
Prinston Pharmaceutical Inc recalls Solco Healthcare US Valsartan, USP, 320 MG Tablets, 90-count bottle,Rx Only Manufactured by: Zhejiang Huahai Pharmaceuti
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 1, 2018DrugsFDA
Prinston Pharmaceutical Inc recalls Solco Healthcare US Valsartan, USP, 160 MG Tablets, 90-count bottles, Rx Only Manufactured by: Zhejiang Huahai Pharmaceu
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 1, 2018DrugsFDA
Prinston Pharmaceutical Inc recalls Solco Healthcare US Valsartan, USP, 80 MG Tablets, 90-count bottle, Rx Only Manufactured by: Zhejiang Huahai Pharmaceuti
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 1, 2018DrugsFDA
Prinston Pharmaceutical Inc recalls Solco Healthcare US Valsartan, USP, 40 MG Tablets, 30- count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceu
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
January 17, 2018DrugsFDA
Prinston Pharmaceutical Inc recalls Valsartan Tablets, USP, 160 mg, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xun
Hazard: Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.
June 29, 2016DrugsFDA
Prinston Pharmaceutical Inc recalls Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, Manufactured by: Zhejiang Huahai Pharmaceutical C
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on the immediate container.