Drug major Lupin Limited has initiated a recall of 55,348 bottles of Amlodipine Besylate Tablets. This recall has been initiated for the manufacturing done at the Verna facility in Goa which had earlier received multiple form 483s.
The products were manufactured for Lupin Pharmaceuticals, Inc. Baltimore, Maryland and the recall has been for batches sold in the US and that No recalled product was distributed to any foreign consignees by Lupin.
Amlodipine besylate tablets are a type of medicines known as a calcium channel blocker (CCB). They are used to treat high blood pressure (hypertension) and a type of chest pain called angina. They can be used by itself or with other medicines to treat these conditions
An action basically taken to remove the particular product from the market can be done by either the company itself or by the FDA under its own statutory authority. In this case, it is a Voluntary recall initiated by the company itself.
The recall has been initiated in 2 specific regions alone – the whole of United States and Puerto Rico and it has been classified as a Class III recall which means the exposure to this recalled product is not likely to cause adverse health consequences.
All the 13 lots recalled have a product expiry date of April, 2016
Related Post: Lupin recalls 54,472 vials of Ceftriaxone, first recall post receipt of EIR from USFDA
While not all details have been divulged by the company or the FDA, the simple reason stated is “CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.”
We will wait to see what the company has to add on to this recall. Do note that the company has received an all ok from the US FDA in the form of EIR for one of the form 483s for the Goa facility.
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