Class II · ModerateActive recall
Valsartan Tablets 320 mg USP
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot number473180007A, exp. date 03/31/2020 473180008A, exp. date 03/31/2020 473180011A, exp. date 04/30/2020 473180020B1, exp. date 07/31/2020 473170019B, exp. date 10/31/2019
Where it was soldProduct was distributed to 6 major distributors 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; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
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 byAurolife Pharma LLC, Dayton, NJ 08810 ---
| Distributed by / for | Acetris Health, LLC, Saddle Brook, NJ 07663 |
| NDC | 52343-125-90 |
Show the full FDA record
| Full product label | Valsartan Tablets 320 mg USP, 90 tablet bottles, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 --- NDC 52343-125-90 |
| Recalling firm | Rising Pharmaceuticals, Inc. |
| Distribution | Product was distributed to 6 major distributors who may have further distributed the product throughout the United States. |
| Quantity | 42,016 bottles |
| Recall initiated | 2019-03-07 |
| Report date | 2019-03-27 |
| Recall completed | — |
| Recall number | D-1055-2019 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Saddle Brook 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.