Class II · ModerateRecall completed
Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot number[redacted-phone]-0; Lot #: B0476653-080218; Exp. Date: 08/2019
Where it was soldSouth Carolina
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
| Distributed by / for | RemedyRepack Inc. |
| NDC | 70518-1220-0 |
Show the full FDA record
| Full product label | 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. |
| Distribution | South Carolina |
| Quantity | 3 bottles of 90 tablets (270 tablets overall) |
| Recall initiated | 2018-08-20 |
| Report date | 2018-09-05 |
| Recall completed | 2018-10-10 |
| Recall number | D-1146-2018 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Indiana PA United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.