Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products
Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product lots. This impurity has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.
The products are indicated for the treatment of hypertension.
Theexposureto the impurity N-nitrosodimethylamine (NDMA) that was detected in valsartan product line presents an unacceptable carcinogenic risk to the intended patient population. To date, Prinston Pharmaceutical Inc. has not received any reports of adverse events related to this recall.
| 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 |
The lot number and expiry date information can be found on the manufacturer's unit (see photographs below of packaged product bottle labels).
Retail pharmacies in possession of any unused products: Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-HCTZ Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg, within expiry dates from Jul 2018 to Jan 2020 should immediately return the product by following the instructions below:
- Please contact Solco Customer Service at 1-866-931-9829, Option 5, Monday through Friday (9am to 5pm EST) or email or fax to: customerservice@solcohealthcare.com; 1- 866-931-0709, for the Product Return.
- A call tag, a pre-printed, pre-paid return label will be provided to you for product return; return is free of charge.
- Return products to: DLSS (Dohmen Life Science Services) Attn: Returns Department 4580 S. Mendenhall, Memphis, TN 38141
Solco is notifying its distributors and customers by letter and email and is arranging for return of all recalled products. Pharmacies and wholesalers that received the impacted products will receive a letter as well as a copy of this press release with their recall notification information.
If you have any questions regarding this recall, please call 1-866-931-9829, Option 5, between the hours of 9:00 a.m. to 5:00 p.m. EST Monday through Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this product. Additional information regarding this recall affected products’ lots and expiry dates can be found at http://www.solcohealthcare.com/uploads/news/ValsartanHCTZRecallAffactedLots.pdf or to download at http://www.solcohealthcare.com/uploads/news/ValsartanHCTZRecallAffactedLots.xlsx
Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.
This Product Recall is being made with the knowledge of the United States Food and Drug Administration (FDA).
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