FDA-Drug2018-08-15Class II

Valsartan/HCTZ 160/12.5 mg Tablets, 90-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4311-9

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 160/12.5 mg Tablets, 90-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4311-9

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1037-2018

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