Recall: Prinston Pharmaceutical Inc. dba Solco Healthcare LLC Valsartan Tablets And Valsartan-Hydrochlorothiazide Tablets
On 2018-07-13, the FDA announced that Prinston Pharmaceutical dba Solco Healthcare is conducting a recall on Valsartan Tablets And Valsartan-Hydrochlorothiazide Tablets due to a possible n-nitrosodimethylamine (ndma). The recalled products were sold under the brand name(s) Prinston Pharmaceutical Inc. dba Solco Healthcare LLC during an unspecified time period throughout the regions shown in the map below.
In recent months, there have been 2 drugs recalls due to potential elevated impurity, including piperacillin and tazobactam for injection, methylprednisolone sodium succinate for injection, usp 40mg, 125mg, and 1g and more. Additionally, there have been 22 drug and medical device recalls due to other health hazards as well as 77 food recalls.
Company Contact Information:
Name: Prinston Pharmaceutical dba Solco Healthcare
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Detailed Recall Information
Regions Where Sold: Because the region was not specified, it is assumed that this product was available nationwide.
Product Description: Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg
Brand Name(s): Prinston Pharmaceutical Inc. dba Solco Healthcare LLC
Reason for Recall: Elevated Impurity of N-Nitrosodimethylamine (NDMA)
Official Recall Date: 2018-07-13
Additional information provided by the FDA.gov:
Prinston Pharmaceutical Inc., dba Solco Healthcare LLC., is voluntarily recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the consumer level. Read More.
More information may be available at FDA.gov
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Sources may include Food & Drug Administration (FDA), United States Department of Agriculture (USDA), Health Canada and companies involved with this or a related recall.