Recall: Camber Pharmaceuticals Valsartan Tablets, USP, 40mg, 80mg, 160mg And 320mg
On 2018-08-08, the FDA announced that Camber Pharmaceuticals is conducting a recall on Valsartan Tablets, USP, 40mg, 80mg, 160mg And 320mg due to a possible elevated impurity. The recalled products were sold under the brand name(s) Camber Pharmaceuticals during an unspecified time period throughout the regions shown in the map below.
In recent months, there have been 4 drugs recalls due to potential elevated impurity, including valsartan and valsartan hydrochlorothiazide tablets, valsartan tablets and valsartan-hydrochlorothiazide tablets and more. Additionally, there have been 20 drug and medical device recalls due to other health hazards as well as 84 food recalls.
Company Contact Information:
Name: Camber Pharmaceuticals
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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, USP, 40mg, 80mg, 160mg and 320mg
Brand Name(s): Camber Pharmaceuticals
Reason for Recall: N-Nitrosodimethylamine (NDMA) Elevated Impurity
Official Recall Date: 2018-08-08
Additional information provided by the FDA.gov:
As a precautionary measure, Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg to the hospital, retail and consumer level. This recall of multiple batches of Valsartan Tablets was prompted due to the detection of trace amounts of N-Nitrosodimethylamine (NDMA), a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit - I (API manufacturer). 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.