FDA-Drug2018-10-31Class II
Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays Original NDC 13668-0325-30 Repackaged NDC 70518-1220-00
RemedyRepack Inc.
Hazard
CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
Sold states
Product was distributed to a medical facility in South Carolina
Affected count
2 bottles of 90 tablets (180 tablets)
Manufactured in
625 Kolter Dr Ste 4, N/A, Indiana, PA, United States
Products
Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays Original NDC 13668-0325-30 Repackaged NDC 70518-1220-00
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0093-2019Don't want to check this manually?
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