FDA-Drug2018-09-12Class II
AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-887-90
Avkare Incorporated
Hazard
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Sold states
Nationwide
Affected count
19109 bottles
Manufactured in
114 S 1st St, N/A, Pulaski, TN, United States
Products
AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-887-90
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1175-2018Don't want to check this manually?
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