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Recall of Valsartan Tablets Due to Cancer Risk

The recall has spread globally with Health Canada and the European Medicines Agency having also recalled drugs using valsartan provided by Zhejiang Huahai. 

The valsartan tablets (dosages 40mg to 320mg) the FDA has recalled include products from the following drug companies:

  • A-S Medication Solutions (labeled as Solco Healthcare)
  • Bryant Ranch Prepack
  • HJ Harkins Company
  • Northwind Pharmaceuticals
  • Prinston Pharmaceutical Inc. (labeled as Solco Healthcare)
  • Teva Pharmaceuticals Industries Ltd. (some labeled as Actavis, some as Major Pharmaceuticals)

Recalled valsartan/hydrochlorothiazide tablets (dosages range from 80mg/12.5mg to 320mg/25 mg) include products from these drug companies:

  • AvKARE
  • A-S Medication Solutions
  • Northwind Pharmaceuticals
  • Prinston Pharmaceutical (labeled as Solco Healthcare)
  • Proficient Rx
  • Remedy Repack
  • Teva Pharmaceuticals (some labeled as ACtavis)

Not all valsartan products contained NDMA, the agency says; the FDA has a list of drugs with NDMA and those not affected on its website.

Consumers taking any medication with valsartan can compare their prescription bottle to the FDA’s list to determine if their drugs have been recalled. Patients can also contact their pharmacist, who may be able to provide valsartan from a drug maker not involved in the recall, the FDA says.

[8/24/2018] Torrent Pharmaceuticals Limited is expanding its voluntary recall to all lots of unexpired valsartan-containing drug products due to the detection of NDMA in the active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals.

RemedyRepack, a repackager of Torrent’s valsartan/amlodipine/hydrochlorothiazide (HCTZ) tablets, has also recalled.

FDA has updated the list of valsartan products under recall and the list of valsartan products not under recall.

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

For Immediate Release

August 8, 2018

More at FDA.gov
By |2018-11-30T15:52:25+00:00August 9th, 2018|Local News, Medical Recalls, Recalls|0 Comments