Cholesterol Drug Recalls Hit Major Manufacturers

Orient Pharma and AvKARE Initiate Large-Scale Pitavastatin Recalls

In a significant development for the pharmaceutical industry, two major manufacturers have announced recalls of the cholesterol-lowering drug pitavastatin due to impurity concerns. Taiwanese drugmaker Orient Pharma and Tennessee-based AvKARE have independently initiated recalls affecting nearly 80,000 bottles of the medication.

Orient Pharma, manufacturing for Teva Pharmaceuticals, has recalled 57,504 bottles of pitavastatin. The recall, launched on June 11, impacts products distributed in New Jersey. Separately, AvKARE issued a recall on June 26, affecting 10,133 bottles of the same drug, with distribution reaching nationwide.

Impurity and Degradation Specifications Prompt Action

Both recalls stem from failed impurity and degradation specifications, highlighting the industry's ongoing challenges in maintaining stringent quality controls. The FDA has classified these recalls as Class III, indicating that while regulations have been violated, the use of these products is unlikely to cause adverse health consequences.

AvKARE's recall encompasses multiple lots of pitavastatin with expiration dates ranging from October 31, 2025, to September 30, 2026. This extended timeframe underscores the importance of long-term stability in pharmaceutical products and the need for rigorous testing throughout a drug's shelf life.

Statin Recalls: A Recurring Industry Challenge

This isn't the first time statins have faced recall issues. In 2021, Dr. Reddy's recalled hundreds of thousands of bottles of atorvastatin, a generic version of Lipitor, also due to impurity concerns. That recall, like the current ones, was classified as Class III and affected a substantial quantity of medication – 10,440 90-count bottles and 224,710 500-count bottles.

These recurring recalls highlight the pharmaceutical industry's ongoing struggle with quality control, particularly for widely prescribed medications. Statins, including pitavastatin, are among the most commonly used drugs in the United States. The CDC estimated that in 2018, approximately 92 million adults in the country were taking statins, representing about 35% of adults aged 40 or older.