A week after two more blood pressure drugs were recalled because they have a possible cancer-causing ingredient, the U.S. based Mylan Pharmaceuticals expanded its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within dates of expiration.
Some of the batches aren’t due to expire until August 2020.
▪ The 104 additional lots include 26 lots of Amlodipine and Valsartan tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths).
▪ Also: 51 lots of Valsartan tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochlorothiazide tablets, USP (80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg and 320mg/25mg strengths).
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“Out of an abundance of caution, these products are being recalled due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Valsartan, USP, manufactured by Mylan Laboratories Limited,” the Food and Drug Administration posted Tuesday.
According to the Food and Drug Administration, NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes. NDEA has been classified as a “probable human carcinogen” according to the International Agency for Research on Cancer.
The finished products are manufactured by Mylan Pharmaceuticals Inc. and Mylan Laboratories Limited. These batches were distributed domestically between March 2017 and November 2018.
The full list of expanded recalled batches can be viewed at https://www.fda.gov/Safety/Recalls/ucm627647.htm.
On Nov. 29, the FDA released a warning letting to Jun Du, the executive vice president of Zhejiang Huahai Pharmaceutical Co. in China. ZHP is the manufacturer of the active pharmaceutical ingredient found in Valsartan that has been the subject of the ongoing FDA investigation into “probable cancer-causing impurities in certain commonly prescribed heart medicines,” according to a release posted on Dec. 11.
The letter outlined several manufacturing violations at the company’s Chuannan facility that included impurity control, change control and cross contamination from one manufacturing process line to another,” according to the FDA.
“We’re continuing to investigate and take action to protect patient health and safety from products in this angiotensin II receptor blocker class that have been found to have dangerous impurities,” said FDA Commissioner Scott Gottlieb in Wednesday’s news release. “As part of that investigation, we’ve uncovered serious manufacturing violations at ZHP, which is one of the manufacturing facilities that has been linked to these products. The issues cited in the warning letter are associated with the nitrosamine impurities found in these drugs, and these violations reveal a disturbing lack of oversight at this API manufacturer that puts patients at risk.”
Late last month, Teva Pharmaceuticals pulled all lots of Amlodipine/Valsartan and Amlodipine/Valsartan/Hydrochlorothiazide combination tablets for the same reason: too much NDEA in its Valsartan, the active ingredient made by Mylan India.
In November, Mylan also recalled 15 heart attack and blood pressure medications and Sandoz recalled Losartan blood pressure meds.
In July, five medications of Valsartan/Hyrdrochlorothiazide blood pressure drugs manufactured by Major Pharmaceuticals, Teva Pharmaceuticals and Solco Healthcare were recalled.
According to the FDA, Valsartan is used for the treatment of high blood pressure and for the treatment of heart failure, and to reduce cardiovascular mortality following myocardial infarction.
Valsartan in combination with Amlodipine or Hydrochlorothiazide is used for the treatment of high blood pressure.
The recall suggests that patients who use these medications should contact their pharmacist or physician for advice on alternative treatment before returning their medication.
The recall warning made clear that patients who are on Valsartan should continue taking their medication “because the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment.”
Mylan, the FDA said, is notifying its distributors and customers by letter and is arranging for the return of all recalled products.
The FDA suggested that consumers, including retailers, who have these recalled pills could contact Stericycle at 888-406-9305 for the return of the recalled product during business hours Monday through Friday.
In the FDA’s latest release, concerning the warning letter to the Chinese pharmaceutical company, the FDA noted that there may be confusion regarding which products are affected by the recent recalls and which are not.
“It is important to note that the active pharmaceutical ingredient in these products besides Valsartan, Irbesartan or Losartan are not necessarily under a recall. As an example, Valsartan/Amlodipine/Hydrochlorothiazide is one product that has been recalled. Neither Amlodipine or Hydrochlorothiazide are currently under recall,” the FDA said.
“Similarly, Losartan potassium and Hydrochlorothiazide 100mg/25mg is a recalled product. The agency asks the public to pay careful attention to the agency’s website for the most accurate and up-to-date information. The agency’s website provides lists of Valsartan products under recall, Valsartan products not under recall, and Irbesartan products under recall for patients, health care providers and pharmacists to accurately confirm which products are affected,” the FDA said.