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Drug maker Ranbaxy Laboratories, ailing from bans imposed by the US Food and Drug Administration (FDA) on several of its Indian factories, has once again recalled some batches of its generic version of cholesterol-lowering Lipitor drug in the US after a dosage mix-up was detected.
Owned by Japan’s Daiichi Sankyo, the company voluntarily recalled 64,626 bottles containing atorvastatin calcium (generic Lipitor) tablets after a pharmacist found a 20-mg tablet in a sealed bottle marked for 10-mg tablets, an enforcement report posted on the FDA’s website said. The bottles were recalled in in January, the report said.
In November 2012, Ranbaxy had recalled certain lots of the drug in the US after discovering glass particles in the bottles. Subsequently, the company had stopped making the drug, until February last year.
The FDA classified the latest Lipitor recall as Class II, signifying a remote chance of severe adverse consequences or death due to the product flaw. The newly recalled bottles were distributed in 2012 and expire in May this year.
While analysts say the financial implication of the latest recall is insignificant, the company’s reputation might take a hit. Ranbaxy is already struggling to resolve manufacturing issues at some its factories in India. The US drug regulator has banned four of Ranbaxy’s key factories in the country after it found these lacking in following manufacturing norms. Three formulation making factories in Paonta Sahib (Himachal Pradesh), Dewas (Madhya Pradesh) and Mohali (Punjab). The latest to face the ban is its main active pharmaceutical ingredient (API) manufacturing factory in Toansa (Punjab).
Ranbaxy, fined $500 million in the US early last year after it pleaded guilty to criminal charges, is still undergoing consent decree at all these four plants in India. The company is allowed to sell only those products in the US made at its Ohm Laboratories in New Jersey. According to Ranbaxy’s 2012 annual report, North America contributed 44 per cent of the consolidated global revenue of $2.3 billion.
ILLNESS CONTINUES
- Nov 2012: Ranbaxy recalled some batches of Lipitor generic from the US market after it discovered contamination through presence of glass particles
- May 2013: Ranbaxy pleaded guilty and agreed to pay $500 million in penalty to US authorities
- Sep 2013: Ranbaxy’s Mohali plant received import alert
- Jan 2014: Ranbaxy voluntarily recalled 64,626 bottles of Lipitor generic after dosage mix-up detected
- Jan 2014: US drug regulator imposed import alert on Ranbaxy’s Toansa (Punjab) factory
- Feb 2014: Ranbaxy temporarily held shipments from the active pharmaceutical ingredient factories in Toansa and Dewas (MP) for examining processes and controls
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