Legacy Pharmaceutical Packaging said it’s recalling 40 lots of Losartan Tablets, which are used to treat heart failure and high blood pressure.
According to a notice posted on the U.S. Food and Drug Administration (FDA) website, the recall was prompted due after “trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA),” which is potentially carcinogenic, was found. It was also triggered due to Camber Pharmaceuticals issuing a voluntary recall of the same medication, manufactured by Hetero Labs in India.
“NMBA is a potential human carcinogen. To date, Legacy has not received any reports of adverse events related to this recall,” said the FDA notice on March 25.
The repackaged lots under recall are Losartan Potassium, USP, 25mg and NDC 68645-577-54; Losartan Potassium, USP, 50mg and NDC 68645-578-54; and Losartan Potassium, USP, 100mg and NDC 68645-579-54.
More lot numbers can be seen on the FDA’s website, which said that they “can be identified by checking the product name and repackaged lot number on the bottle containing these products.”
The Losartan Potassium was distributed to pharmacies around the United States, and Legacy is notifying consumers and distributors about the recall.
“Consumers with questions regarding this recall can contact your dispensing pharmacy during normal business hours. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product,” the agency advised.
Any adverse reactions to the product should be reported to the FDA.
Legacy on March 15 recalled three repackaged lots of Losartan tablets, which was “prompted due to Torrent Pharmaceuticals LTD issuing” a voluntary recall of its own, the FDA stated. Those pills were made by Hetero Labs.
For a list of other losartan recalls, the FDA’s website has details.
For a list of valsartan recalls until March 1, the FDA’s website has details.
For a list of irbesartan recalls until March 1, the FDA’s website has details.
FDA Warning on Shortage
“Valsartan products are in shortage, and we know that other types of products may fall into shortage soon,” FDA Commissioner Dr. Scott Gottlieb and FDA director of drug evaluation and research Dr. Janet Woodcock said in the joint statement.
In July, the FDA carried out lab tests on valsartan-containing medications manufactured by a company in China, and the agency discovered the presence of NDMA and NDEA. According to the Environmental Protection Agency, NDMA is found in rocket fuel, lubricants, and other additives.
“These two substances are known environmental contaminants and found in water and foods, including meats, dairy products, and vegetables. But their presence in drug products is not acceptable,” the FDA statement said at the time.
The issue surfaced in the summer of 2018 after the FDA was informed that an active ingredient manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. in Linhai, China, had NDMA inside.
“We also issued them a warning letter outlining several manufacturing violations, including impurity control, change control, and cross-contamination from one manufacturing process line to another,” the FDA statement last month said.
After an investigation into Zhejiang’s manufacturing process, the FDA discovered a change that likely led to the cancer-causing chemicals being introduced. The impurity was also not detected by global health agencies, including the FDA, for some time until last summer.