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Recall Notice: Heritage Pharmaceuticals Inc. Recalls Losartan Potassium 25 mg, 50 mg, and 100 mg Tablets

Date: 05/06/19

Recall Notice: Heritage Pharmaceuticals Inc. Recalls Losartan Potassium 25 mg, 50 mg, and 100 mg Tablets

On May 6, 2019 the U.S. Food and Drug Administration (FDA) announced that Heritage Pharmaceuticals Inc. was recalling 19 Lots of Losartan Potassium tablets to the consumer level due to presence of NMBA exceeding the FDAs acceptable exposure limit. 

The FDA press release states the following:
Vivimed Life Sciences Pvt Ltd (Vivimed) is recalling 19 lots of Losartan Potassium Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. Due to the detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) – that is above the US Food & Drug Administration’s interim acceptable exposure limit of 9.82 ppm. Based on the available information, the risk of developing cancer in a few patients following long-term use of the product containing high levels of the impurity NMBA cannot be ruled out. 

This product is made by Vivimed at its Plant in Alathur, Chennai, India and Distributed by Heritage Pharmaceuticals Inc, East Brunswick NJ (Heritage). To date, neither Vivimed nor Heritage has received any reports of adverse events related to this recall.

Losartan Potassium is indicated for the treatment of hypertension, hypertensive patients with left ventricular hypertrophy, nephropathy in Type 2 diabetic patients and is packaged in 90-count and 1000-count bottles. The lots were manufactured by Vivimed at its Plant in Alathur, Chennai, India and Distributed by Heritage Pharmaceuticals Inc, East Brunswick NJ (Heritage). Losartan Potassium Tablets were distributed Nationwide to Wholesalers, Distributors, Retail Pharmacies, and Mail Order Pharmacies.

Review the Full FDA Press Release

For questions or concerns, please reach out to the Envolve Pharmacy Solutions’ Pharmacy Department by calling 1-800-782-2221.