Tyler Patchen
News Reporter
A blood pressure medication produced by generics giant Sun Pharmaceuticals is being recalled.
Sun Pharma is voluntarily recalling diltiazem hydrochloride in a 360 mg dosage form across the US, according to an enforcement report from the FDA. The drug is used to treat high blood pressure and angina.
The FDA’s report said the recall stems from a “failed impurity specification” during testing as well as another failed test at an FDA laboratory. The report said that the recalled product was produced by Sun Pharma’s facility in Halol, India, a city in the nation’s southwest state of Gujarat. The recall itself was issued on Jan. 13 of this year.
Five lots of medication, over 34,000 bottles, were affected by the recall. The FDA has also given the recall a Class II designation. According to the FDA, this means that this is a situation in which the use or exposure to a certain product may cause temporary or reversible health consequences or where serious health issues are a remote possibility.
Endpoints News reached out to Sun Pharmaceuticals but did not get a response by press time.
This recall comes as Sun Pharma’s facility in Halol has been facing some serious scrutiny from US regulators over the past year. In December, the Halol facility was given an import alert from the FDA, meaning that the agency had enough evidence to detain products without examination and refuse their entry into the US market until the issues were corrected and the facility became compliant with cGMP. Several products have been under the alert, but diltiazem hydrochloride was not on the list.
Form 483 reveals quality control questions and lack of training at Sun Pharma’s plant in India. The site was also inspected from April 26 to May 9 last year, with the 23-page inspection report detailing a lack of cleaning and sanitization for equipment and utensils, as well as a lack of training for employees, among other observations.
Leave a Reply