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Valsartan containing products

Published Jan 16, 2024Source

What we know

Product Name MA Holder Manufacturer API source Decision of FDA & Date of letter Valsotens Tablets 80mg Actavis Limited Actavis Limited, UK Zhejiang Huahai Pharmaceuticals, Linhai, China. Recall, 11th Sept 2018 Valsotens Tablets 160mg Actavis Limited Actavis Limited, UK Zhejiang Huahai Pharmaceuticals, Linhai, China. Recall, 11th Sept 2018 Dopcor 80mg Denk Pharma GmbH & Co. KG, Germany Denk Pharma GmbH & Co. KG, Germany Zhejiang Huahai Pharmaceuticals, Linhai, China Recall, 12th July 2018 Valsar-Denk 80mg Aspen Pharmacare Holdings Torrent Pharmaceuticals Limited, Gujarat, India Zhejiang Huahai Pharmaceuticals, Linhai, China 05-2020 Primadol 500mg Tablet (Paracetamol 500mg) Kinapharma Limited, Accra 16021 NIL 06-2020 Palidar Tablets (Sulphadoxine 500mg, Pyrimethamine 25mg) Phyto-Riker (Ghana) Pharmaceuticals Ltd. Accra 051-U11684 11-2014 10-2018 Product Recalls FDA/USP antimalarials and analgesics survey Valsartan containing products- due to contamination of api with nitrosodiethylamine (ndea) and nitrosodimethylamine (ndma) impurities Adulterated herbal medicines/ food supplements Other product recalls (batch specific)

Safety advice

  • Stop using or purchasing the product if the notice asks you to.
  • Keep receipts, batch numbers and packaging — they help with returns or investigations.
  • Share this alert with anyone who might be affected, especially relatives and colleagues.
  • If you believe you’ve been harmed, contact the official source or a relevant authority.

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