American Health Packaging recalls Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, Rx Only, Packaged and Distributed by: Amer
Recalled March 27, 2019 · FDA recall D-1047-2019 · American Health Packaging
Hazard
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient. · FDA Class II
Units
3337 cartons
Sold at
Nationwide USA and Puerto Rico
Description
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Product
Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 (Individual Dose NDC:60687-139-11, Carton NDC#: 60687-139-01)
Manufacturer(s)
American Health Packaging
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →