Solco Healthcare is recalling all lots of Valsartan tablets and Valsartan-Hydrochlorothiazide tablets, which are used for treatment of hypertension, or high blood pressure.
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 are being recalled:
| Product | NDC Code | Lot Number | Expiry Dates | Distribution Date |
|---|---|---|---|---|
| VALSARTAN TABLETS 40MG 30CT | 43547-367-03 | All lots | From Jul 18 to Jan 20 | Oct 2015 – Jun 2018 |
| VALSARTAN TABLETS 80MG 90CT | 43547-368-09 | All lots | From Jul 18 to Jan 20 | Oct 2015 – Jun 2018 |
| VALSARTAN TABLETS 160MG 90CT | 43547-369-09 | All lots | From Jul 18 to Jan 20 | Oct 2015 – Jun 2018 |
| VALSARTAN TABLETS 320MG 90CT | 43547-370-09 | All lots | From Jul 18 to Jan 20 | Oct 2015 – Jun 2018 |
| VALSARTAN/HCTZ 80MG/12.5MG 90CT TABLETS | 43547-311-09 | All lots | From Jul 18 to Jan 20 | Jun 2016 – Jun 2018 |
| VALSARTAN/HCTZ 160MG/12.5MG 90CT TABLETS | 43547-312-09 | All lots | From Jul 18 to Jan 20 | Jun 2016 – Jun 2018 |
| VALSARTAN/HCTZ 160MG/25MG 90CT TABLETS | 43547-313-09 | All lots | From Jul 18 to Jan 20 | Jun 2016 – Jun 2018 |
| VALSARTAN/HCTZ 320MG/12.5MG 90CT TABLETS | 43547-314-09 | All lots | From Jul 18 to Jan 20 | Jun 2016 – Jun 2018 |
| VALSARTAN/HCTZ 320MG/25MG 90CT TABLETS | 43547-315-09 | All lots | From Jul 18 to Jan 20 | 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.
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