Sun Pharma recalls generic for high blood pressure after failed FDA lab test

Generics giant Sun Pharma has found itself at the center of another nationwide recall in the U.S.

In a recent FDA enforcement report, the agency said the firm is pulling more than 34,000 bottles of generic diltiazem hydrochloride because the drug batch failed "stability testing and failed dissolution testing” at an FDA laboratory.

The drug is used to treat high blood pressure, chest pain and certain heart rhythm disorders. 

Sun Pharma made the pills at its Halol manufacturing plant in Gujarat, India. The pills were distributed nationwide. 

The company started the recall Jan. 13, but the agency classified it as a Class 2 recall earlier this month. Class 2 recalls cover situations that  “may cause” temporary health consequences or a remote chance of serious health outcomes.  

Sun's Halol plant is no stranger to FDA dings. In December, the FDA slapped the plant with an import alert, stipulating that products made there would be barred from U.S. entry until the company adheres to FDA standards. At the time, Sun said in a filing that it was cooperating with the FDA and would “undertake all necessary steps” to resolve the issues.

Shortly after, the plant received an FDA warning letter from the same FDA inspection. The FDA recommended Sun hire a consultant to help the plant meet manufacturing standards.

Sun’s last recall was in June, when the company voluntarily recalled 50,680 vials of testosterone cypionate injection because of water leakage at its Halol plant.

Outside of Sun, recent recalls include Spectrum Laboratory Products’ voluntary recall of three lots of bulk compound epinephrine after customers found discoloration of the drug. Plus, Macleods Pharma recently pulled 10,052 bottles of levofloxacin due to labeling issues, its third recall in the span of a year.