Ranbaxy suspends atorvastatin manufacturing after recall
pharmafile | November 30, 2012 | News story | Manufacturing and Production |Â Â FDA, Ranbaxy, atorvastatin, recallÂ
Ranbaxy Laboratories has called a halt to manufacturing its generic atorvastatin product until it can get to the bottom of a contamination incident, which prompted a recall earlier this month.
The Indian pharma company recalled more than 40 lots of its 10mg, 20mg and 40mg atorvastatin tablets in 90- and 500-count bottles early November due to possible contamination with very small glass particles, similar to the size of a grain of sand.
“Ranbaxy has decided to stop manufacturing atorvastatin until it has thoroughly investigated the cause of the glass particulates and remedied the problem,” said the FDA in a statement.
“Based on the information from Ranbaxy and from the FDA’s initial assessment, the possibility of adverse events related to the recalled product appears to be low, and if any adverse events are experienced, they would be temporary,” it added.
The agency has previously warned that shortages could result from the recall and manufacturing suspension, but said this is now unlikely and it is working with other manufacturers to ensure adequate market supply.
Ranbaxy was cleared to start selling atorvastatin made at its US facility Ohm Laboratories towards the end of 2011, and started supplying the US market from a plant in Mohali, India, once an FDA import ban for the product was lifted in April 2012.
The company has not revealed where the recalled atorvastatin lots were manufactured, but the FDA has said the manufacturing suspension also affects production of the atorvastatin active pharmaceutical ingredient (API) in India.
Imports of a number of Ranbaxy’s other products remain restricted because of quality issues at manufacturing facilities in India that resulted in the company signing a consent decree with the FDA earlier this year.
The Mohali plant is not covered by the consent decree, which applies to Ranbaxy’s facilities in Dewas, Paonta Sahib and Batamandi.
Phil Taylor
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