A previous recall for three repackaged lots of a blood pressure medication that may contain a cancer-causing impurity was expanded Wednesday to include a fourth lot. It's the latest in nearly two dozen such recalls that started last summer.
Legacy Pharmaceutical Packaging, LLC, says this involved Losartan Tablets USP 50mg. The expanded recall was prompted due to Torrent Pharmaceuticals issuing a nationwide recall, according to Legacy, because of the detection of trace amounts of N-Nitroso N-Methyl 4-aminobutyric acid (NMBA).
The 30-count bottles of Losartan Potassium, USP, 50mg, have an NDC number of 68645-494-54.
The lot numbers involved in the earlier recall were 180190 and 180191 (with an October 2020 expiration date) and 181597 (with a February 2021 expiration). The new lot is 181598 (with a February 2021 expiration).
The general advice with all these recalls has been to continue using the product until seeking alternatives with a physician due to the risk of suddenly ending treatment. The FDA has said in the past that the cancer risk is low.
The FDA has said the impurities might be happening when specific chemicals and reaction conditions are present in the manufacturing process of the drug’s API (active pharmaceutical ingredients). It may also result from the reuse of materials, such as solvents.
Consumers with questions can contact Inmar at 1-877-538-8443, Monday – Friday, 9 a.m. – 5 p.m. EDT. Consumers should contact their physician or healthcare provider if they have that may be related to taking or using this drug product.