A trace amount of an unexpected impurity -- N-nitrosodimethylamine (NDMA) -- was detected. NDMA has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.
The company has received no reports of adverse events related to this recall.
The following products, with expiry dates from Jul 18 to Jan 20, are being recalled for all lots:
| Product | NDC Code | Distribution Date |
|---|---|---|
| VALSARTAN TABLETS 40MG 30CT | 43547-367-03 | Oct 2015 – Jun 2018 |
| VALSARTAN TABLETS 80MG 90CT | 43547-368-09 | Oct 2015 – Jun 2018 |
| VALSARTAN TABLETS 160MG 90CT | 43547-369-09 | Oct 2015 – Jun 2018 |
| VALSARTAN TABLETS 320MG 90CT | 43547-370-09 | Oct 2015 – Jun 2018 |
| VALSARTAN/HCTZ 80MG/12.5MG 90CT TABLETS | 43547-311-09 | Jun 2016 – Jun 2018 |
| VALSARTAN/HCTZ 160MG/12.5MG 90CT TABLETS | 43547-312-09 | Jun 2016 – Jun 2018 |
| VALSARTAN/HCTZ 160MG/25MG 90CT TABLETS | 43547-313-09 | Jun 2016 – Jun 2018 |
| VALSARTAN/HCTZ 320MG/12.5MG 90CT TABLETS | 43547-314-09 | Jun 2016 – Jun 2018 |
| VALSARTAN/HCTZ 320MG/25MG 90CT TABLETS | 43547-315-09 | Jun 2016 – Jun 2018 |
What to do
Solco is notifying customers by letter and email and is arranging for return of all recalled products.
Consumers with questions may contact the company at (866) 931-9829, option 5, Monday through Friday, 9:00 a.m. – 5:00 p.m. (EST), or by email at customerservice@solcohealthcare.com.