Reported Jan 23, 2019 · Ongoing
Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo…
Aurobindo Pharma USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Aurobindo Pharma USA Inc. · 279 Princeton Hightstown Rd · East Windsor, NJ · 08520-1401
Is this the product you have?
- Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles, Rx Only
- Manufactured forAurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-551-90
- Lot codes and dates
24 of 24 products
Products covered by this recall # Product as published 1 Lot # HTSB17049-A, exp. date 08/2020 2 Lot # HTSB17054-A, exp. date 10/2020 3 Lot # HTSB17055-A, exp. date 10/2020 4 Lot # HTSB17056-A, exp. date 10/2020 5 Lot # HTSB17057-A, exp. date 10/2020 6 Lot # HTSB17058-A, exp. date 10/2020 7 Lot # HTSB17059-A, exp. date 10/2020 8 Lot # HTSB17060-A, exp. date 10/2020 9 Lot # HTSB17062-A, exp. date 10/2020 10 Lot # HTSB17066-A, exp. date 10/2020 11 Lot # HTSB17067-A, exp. date 11/2020 12 Lot # HTSB17068-A, exp. date 11/2020 13 Lot # HTSB17069-A, exp. date 11/2020 14 Lot # HTSB18001-A, exp. date 12/2020 15 Lot # HTSB18002-A, exp. date 12/2020 16 Lot # HTSB18003-A, exp. date 12/2020 17 Lot # HTSB18004-A, exp. date 12/2020 18 Lot # HTSB18005-A, exp. date 12/2020 19 Lot # HTSB18006-A, exp. date 12/2020 20 Lot # HTSB18007-A, exp. date 12/2020 - Amount recalled
- 111,239 bottles
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Aurobindo Pharma USA Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.