Lipitor lawyers at Pintas & Mullins Law Firm are warning generic Lipitor users that they may need to stop taking the medication immediately. Shockingly, there may be harmful glass particles inside the popular cholesterol drug.
Earlier this month, Ranbaxy Pharmaceuticals voluntarily recalled dozens of lots of the company’s generic Lipitor tablets, known as Atorvastatin The 41 recalled lots are in dosage strengths of 10, 20, and 40 mg, and packaged in bottles of 90 and 500 tablets. These recalled tablets may be contaminated with dangerous particles of glass. Consumers using this product should stop taking the tablets immediately.
The FDA informed consumers of the contaminated cholesterol drug and reported that Ranbaxy will cease all production of Atorvastatin while investigations are underway. Although the FDA is now involved, the vice president of one major pharmacy, Express Scripts, is telling patients that it will not refund the recalled lots, and they should continue taking them as normal.
The Express Scripts executive maintains that the recall was merely ‘pharmacy-level,’ meaning that only pharmacies should stop distributing the drug. Several CVS pharmacies are telling patients similar information, saying it is okay to keep taking the recalled tablets if they are already at home, though CVS is willing to refund the Atorvastatin.
In its statement the FDA advises consumers to contact their pharmacist to inquire about whether their tablets were part of the recalled lots. Pharmacists, however, are concerned because they have no way of discerning what lot numbers individual tablets came from. It is also concerning that the FDA warning took so long.
According to CNN, Ranbaxy has a history of similar manufacturing glitches. An additional recent recall involved mispackaged products. Ranbaxy is based near New Delhi, India, and is the 12th largest generics maker in the world. In 2008, the FDA banned the company from importing dozens of drugs into the United States due to an array of manufacturing problems and reports of forged data submitted to the FDA. The ban was lifted only seven months ago when the company entered into a 5 year agreement with the FDA and Department of Justice, agreeing to improve oversight of development and manufacturing to comply with U.S. standards.
Currently, Ranbaxy is responsible for about 40% of the U.S. market for
the popular cholesterol drug; other companies that distribute similar
products are Mylan and Watson Pharmaceuticals. About 1 million prescriptions
of the drug are sold each week, and Ranbaxy was leading in world production.
Mylan even sued the FDA in issues regarding Ranbaxy.
Bloomberg reports that the drug will be off the market for at least two weeks, and that the company’s shares have already declined 3.1 percent. Ranbaxy has an additional factory in central New Jersey at Ohm Laboratories. When it was made clear the infected tablets were exclusively from the New Delhi factory, the FDA cleared sales from the New Jersey location.
Consumers expect and deserve to be sold medication that is safe, effective, and high quality. The FDA report can be found here, and those taking such cholesterol medication are urged to keep up to date with reports and findings concerning Ranbaxy and Atorvastatin tablets. Drug recall attorneys at Pintas & Mullins Law Firm offer free consultations to anyone experiencing adverse health effects from this medication.