Prinston Pharmaceutical recalls
FDA enforcement reports naming Prinston Pharmaceutical Inc as the recalling firm.
- Recall reports
- 16
- Class I (serious)
- 0
- Most recent report
- Feb 6, 2019
- Feb 6, 2019Irbesartan and Hydrochlorothiazide Tablets, USP 150/12Drug · Prinston Pharmaceutical IncCGMP 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.Class II
- Feb 6, 2019Irbesartan and Hydrochlorothiazide Tablets, USP 300/12Drug · Prinston Pharmaceutical IncCGMP 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.Class II
- Feb 6, 2019Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huahai Pharmac…Drug · Prinston Pharmaceutical IncCGMP 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.Class II
- Feb 6, 2019Irbesartan and HydrochlorothiazideTablets, USP 150/12Drug · Prinston Pharmaceutical IncCGMP 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.Class II
- Feb 6, 2019Irbesartan and Hydrochlorothiazide Tablets, USP 300/12Drug · Prinston Pharmaceutical IncCGMP 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.Class II
- Aug 1, 2018Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12Drug · Prinston Pharmaceutical IncCGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.Class II
- Aug 1, 2018Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets, 90-co…Drug · Prinston Pharmaceutical IncCGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.Class II
- Aug 1, 2018Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tablets, 90-co…Drug · Prinston Pharmaceutical IncCGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.Class II
- Aug 1, 2018Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 80 MG/12Drug · Prinston Pharmaceutical IncCGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.Class II
- Aug 1, 2018Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/12Drug · Prinston Pharmaceutical IncCGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.Class II
- Solco Healthcare US Valsartan, USP, 40 MG Tablets, 30- count bottle, Rx Only, Manufactu…
- Solco Healthcare US Valsartan, USP, 80 MG Tablets, 90-count bottle, Rx Only Manufacture…
- Solco Healthcare US Valsartan, USP, 160 MG Tablets, 90-count bottles, Rx Only Manufactu…
- Solco Healthcare US Valsartan, USP, 320 MG Tablets, 90-count bottle,Rx Only Manufacture…
- Valsartan Tablets, USP, 160 mg, 90-count bottles, Rx Only, Manufactured by: Zhejiang Hu…
- Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12
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