FDA Recalls Blood Pressure and Heart Failure Medication

SAN ANGELO, TX — (Press Release) 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.

The exposure to 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.

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 expiration 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: [email protected]; 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.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This product recall is being made with the knowledge of the United States Food and Drug Administration.