Over 64 000 Bottles of Ranbaxy's Generic Lipitor Recalled
Medscape Medical News
March 10, 2014
SILVER SPRING, MD ? Indian drug company Ranbaxy is recalling more than 64 000 bottles of generic atorvastatin in the US after a pharmacist reported finding a 20-mg pill inside a sealed bottle labeled as containing 10-mg pills[1].
News of the recall was posted in the FDA's enforcement report last week.
This is the second time the drug maker has had to recall its generic version of the onetime blockbuster Lipitor. Back in 2012, Ranbaxy recalled multiple batches of the drug after glass particles were found in several doses of its packaged product.
The current recall is the latest blow to the generic drug company, which has faced mounting complaints over its quality control. The FDA moved to ban products made at Ranbaxy's Indian plants after inspectors found what appeared to be a human hair embedded in a tablet during an inspection of a plant last year. The company has not confirmed that the latest mix-up with doses and packaging?the subject of this latest recall?stemmed from the company's New Jersey facility or plants in India.
FDA has designated the recall as class II, meaning that it carries a remote chance of severe adverse consequences or death.
Medscape Medical News
March 10, 2014
SILVER SPRING, MD ? Indian drug company Ranbaxy is recalling more than 64 000 bottles of generic atorvastatin in the US after a pharmacist reported finding a 20-mg pill inside a sealed bottle labeled as containing 10-mg pills[1].
News of the recall was posted in the FDA's enforcement report last week.
This is the second time the drug maker has had to recall its generic version of the onetime blockbuster Lipitor. Back in 2012, Ranbaxy recalled multiple batches of the drug after glass particles were found in several doses of its packaged product.
The current recall is the latest blow to the generic drug company, which has faced mounting complaints over its quality control. The FDA moved to ban products made at Ranbaxy's Indian plants after inspectors found what appeared to be a human hair embedded in a tablet during an inspection of a plant last year. The company has not confirmed that the latest mix-up with doses and packaging?the subject of this latest recall?stemmed from the company's New Jersey facility or plants in India.
FDA has designated the recall as class II, meaning that it carries a remote chance of severe adverse consequences or death.
