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A previous recall of three reconditioned lots of an antihypertensive drug that may contain a cancer-causing impurity was extended on Wednesday to include a fourth batch. It is the latest in date of about twenty reminders of this type that began last summer.
Legacy Pharmaceutical Packaging, LLC, states that it is Losartan 50 mg USP tablets. The expanded recall was motivated by the recall of Torrent Pharmaceuticals nationwide, according to Legacy, due to the detection of traces of N-nitroso-4-aminobutyric acid (NMBA).
Losartan Potassium Dosage Vials, USP 50 mg, have an NDC number of 68645-494-54.
The lot numbers affected by the previous recall were 180190 and 180191 (with an expiry date of October 2020) and 181597 (with an expiry date of February 2021). The new lot is 181598 (with expiration in February 2021).
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In all these recalls, the general advice was to continue using the product until you seek alternatives with a doctor because of the risk of sudden cessation of treatment. The FDA has stated in the past that the risk of cancer is low.
The FDA has stated that impurities could occur when specific chemicals and reaction conditions are present in the process of manufacturing the API (Active Pharmaceutical Ingredients) of the drug. This can also result from the reuse of materials, such as solvents.
Consumers with questions can contact Inmar at 1-877-538-8443, Monday through Friday from 9am to 5pm. EDT. Consumers should contact their doctor or health care provider if they are likely to be involved in taking or using this drug product.
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