A blood pressure medication that is produced by Sun Pharmaceuticals is being voluntarily recalled, according to an “enforcement report” issued by the U.S. Food and Drug Administration (FDA) this week.
According to the FDA, the recall was initiated after “failed impurity specification” that occurred during testing at an FDA laboratory. The product was made at Sun’s facility in Halol, India, and the company voluntarily initiated the recall, the FDA said.
It’s not clear if any adverse events were associated with the recalled lots of diltiazem hydrochloride.
Five lots of medication, or about 34,000 bottles, are affected under the recall, the report said. The lot numbers and expiration dates are: HAC3120A, HAC3121A, Exp. 04/2023; HAC4460A, Exp. 10/2023; HAD0365A, Exp. 12/2023; HAD1452A, Exp. 02/2024.
Other Recalls
In recent months, the FDA has announced similar voluntary recall notices impacting blood pressure medications.In December, Lupin Pharmaceuticals Inc. announced that it is voluntarily recalling four lots of Quinapril tablets due to the presence of nitrosamine, which was observed in recent testing that found levels above the acceptable daily intake level set by regulators. The company said it stopped marketing Quinapril tablets in September of last year.
According to last year’s announcement, Lupin said it has not received any reports of illnesses connected to the impurity issue.
“Nitrosamines are common in water and foods, including cured and grilled meats, dairy products, and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time,” the company said in the announcement.
Several weeks before that, another drug company, Aurobindo Pharma USA, said it would voluntarily recall two lots of blood pressure medication due to the same impurity.
The New Jersey-based firm initiated the recall of quinapril and hydrochlorothiazide in 20-milligram and 12.5-milligram tablets due to the presence of the chemical, which is associated with a higher risk of cancer. Like Lupin, Aurobindo said it did not receive any reports of adverse incidents associated with the medication.
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