FDA-Drug2018-08-08Class II
Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
RemedyRepack Inc.
Hazard
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Sold states
Product was distributed to 3 medical facilities in Florida.
Affected count
3 HDPE 90-count bottles (270 tablets)
Manufactured in
625 Kolter Dr Ste 4, N/A, Indiana, PA, United States
Products
Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1021-2018Don't want to check this manually?
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