Class II · Moderate risk Ongoing
Diovan
Reason Failed Dissolution Specifications
Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
What was recalled
Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles in cardboard trays) MFG Torrent Pharma LTD, Indrad, India 38272, NDC #70518-1220-0
- Recalling firm
- RemedyRepack Inc.
- NDC code
- 70518-1220-0
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1146-2018
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Valsartan recalls
See all
Class II · Moderate risk Terminated
Valsartan Tablets USP 40 mg 30 Scored Tablets Rx Only NDC…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Ongoing
Valsartan Tablets 320 mg USP
Reason CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Class II · Moderate risk Ongoing
Valsartan Tablets 160 mg USP
Reason CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Class II · Moderate risk Ongoing
Valsartan Tablets 80 mg USP
Reason CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
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