FDA-Drug2018-08-29Class II
Valsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx Only, Preferred Pharmaceuticals, Inc., 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807, NDC 68788-6882-9
Preferred Pharmaceuticals, Inc
Hazard
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Sold states
Products were distributed to one distributor in Alabama who may have further distributed the product to the consumer level.
Affected count
9 bottles consisting of 90 tables each bottle
Manufactured in
1250 N Lakeview Ave Ste O, Anaheim, CA, United States
Products
Valsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx Only, Preferred Pharmaceuticals, Inc., 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807, NDC 68788-6882-9
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1107-2018Don't want to check this manually?
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