FDA Announces New Recall of Blood Pressure Drug Over Failed Test

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.

Sun Pharmaceuticals is voluntarily recalling diltiazem hydrochloride in a 360-milligram dosage form across the United States, the FDA report said. Diltiazem hydrochloride is used to treat chest pain, high blood pressure, and some heart rhythm disorders like atrial fibrillation or rapid heartbeats.

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.

The recall was issued earlier this year, according to the FDA report, and appears to have been uploaded on its website on Feb. 14.

The drug agency also gave the recall its Class II designation, which means it is a ” situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote,” the FDA website says.

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.

Sun Pharmaceuticals’ manufacturing site in Halol has faced scrutiny by U.S. regulators over the past several months, with the FDA giving the facility an import alert in December 2022. The FDA import alert implies all future shipments of products made at the plant in Halol in Gujarat state could be refused admission into the U.S. market until the facility becomes compliant with the regulator’s Current Good Manufacturing Practice standards.

“The Company continues to cooperate with the [FDA] and will undertake all necessary steps to resolve these issues and to ensure that the regulator is completely satisfied with the Company’s remedial action,” Sun Pharma said last December (pdf). Sun Pharma, which makes generic drugs, added that it remains “committed to being … compliant and in supplying high-quality products to its customers and patients globally.”

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.

Other than blood pressure medications, the FDA has announced recent recalls of a thyroid drug, epinephrine, and has issued a warning about a brand of eye drops that led to a company-initiated recall.