Class II · ModerateActive recall
Valsartan And Hydrochlorothiazide
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot # HTSA17033-A, exp. date 10/2020 Lot # HTSA17034-A, exp. date 10/2020 Lot # HTSA17035-A, exp. date 10/2020 Lot # HTSA17036-A, exp. date 10/2020 Lot # HTSA17040-A, exp. date 10/2020 Lot # HTSA17041-A, exp. date 11/2020 Lot # HTSA17042-A, exp. date 11/2020 Lot # HTSA17043-A, exp. date 11/2020 Lot # HTSA17037-A, exp. date 10/2020 Lot # HTSA17039-A, exp. date 10/2020
Where it was soldProduct was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
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: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
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
Made byAurobindo Pharma Limited
| Brand name | VALSARTAN AND HYDROCHLOROTHIAZIDE |
| Generic name | VALSARTAN AND HYDROCHLOROTHIAZIDE |
| Active ingredient(s) | HYDROCHLOROTHIAZIDE, VALSARTAN |
| Distributed by / for | Aurobindo Pharma USA, Inc., Dayton, NJ 08810 |
| NDC | 65862-548-90 |
Show the full FDA record
| Full product label | Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-548-90. |
| Recalling firm | Aurobindo Pharma USA Inc. |
| Distribution | Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States. |
| Quantity | 92,616 bottles |
| Recall initiated | 2018-12-31 |
| Report date | 2019-01-23 |
| Recall completed | — |
| Recall number | D-0366-2019 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | East Windsor NJ 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.