FDA-Drug2018-08-15Class II

Valsartan/HCTZ 160/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867,

NuCare Pharmaceuticals Inc
Hazard

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Sold states
Distributed to three customers in Fl and CA
Affected count
N/A
Manufactured in
622 W Katella Ave, N/A, Orange, CA, United States
Products
Valsartan/HCTZ 160/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867,

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1038-2018

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