In merely over 2 Weeks, now for the 4th time, a recall alert has been released for a well-known blood pressure drug that can cause cancer with long-standing usage. It is one of the dozens of drug recalls since previous year’s July. 19 lots are been recalled of Losartan Potassium Tablets by Vivimed owing to the finding of NMBA (N-Nitroso-N-methyl-4-aminobutyric acid). Vivimed stated the impurity is over the acceptable exposure limit of the Food and Drug Administration. The recall states, “Founded on the available data, the threat of developing cancer in some patients after long-standing usage of the product having high impurity NMBA levels cannot be discounted.”
Vivimed stated the drugs were manufactured at its unit in India. The firm states neither it nor dispenser Heritage Pharmaceuticals, has obtained adverse event reports associated with the recall. Throughout these recalls, the FDA has mentioned that the threat of cancer development by consuming these recalled drugs is very less, however, the threat is still there.
In a last month’s video statement, Director of the Center for Drug Evaluation and Research of FDA, Janet Woodcock, said, “The FDA evaluated that if one consumed the very highest dosage of one of the impacted medications over 4 Years, and they took the medication that was the most contaminated, the threat is an additional one case within 8,000 people.”
Likewise, recently another 35 lots of losartan, blood pressure and heart medication, were recalled owing to risky NMBA quantities in the active ingredient. Losartan Potassium USP tablets were made by Teva Pharmaceuticals in strengths of 25 mg and 100 mg for Golden State Medical Supply, as per the FDA-posted, Teva-written recall notice. The tablets were then repackaged by Golden State for retail sale. The website of Golden State recognizes its company’s clients as mail-order pharmacies, governments from local to federal, and military pharmacies.