The FDA upon their latest recent visit has pretty much stopped all exports of the drug or the active ingredient exports to the US and now a US pharmacist found this most recent problem with the mix up with 10 milligram products in the 20 milligram bottles. Once the patent came off Lipitor both Teva and Ranbaxy raced to get the generic product on the market.
It’s a good thing we have “some” checks and balances here with a pharmacist verifying content here in the sealed bottle which of course tells us it came from the manufacturing end of the business. BD
Ranbaxy Laboratories Ltd. (RBXY), India’s largest drugmaker, has recalled two batches of the company’s generic version of Pfizer Inc. (PFE)’s cholesterol-lowering medicine Lipitor after a dose mix-up was detected.
Ranbaxy, a unit of Tokyo-based Daiichi Sankyo Co. (4568), is pulling back pills in 64,626 bottles of atorvastatin calcium in the U.S. after a “product complaint” was received by a pharmacist, the U.S. Food and Drug Administration said on its website. The pharmacist had discovered a 20 milligram tablet in a sealed bottle marked for 10 milligram pills, the FDA said.
The nationwide recall comes on the back of increasing scrutiny on Ranbaxy, all four of whose Indian facilities are suspended from selling in the U.S. for failing to meet the FDA’s current Good Manufacturing Practices. The drugmaker had previously called back its generic version of Lipitor pills in November 2012 for possibly containing small particles of glass.
Soon after visiting the Toansa factory, the FDA banned the export of drug ingredients from the facility to the U.S. The Toansa ban means all four of its Indian plants have been banned from selling in the U.S.