Cipla Recalls Generic Drug in US: Broken Tablets - FDA

By By Rediff Money Desk, New Delhi
Nov 20, 2024 17:21
Cipla is recalling over 1,800 boxes of Lanthanum Carbonate chewable tablets in the US due to reports of broken tablets. The recall, classified as Class II, affects the medication used for high phosphate levels in the blood.
New Delhi, Nov 20 (PTI) Drug major Cipla is recalling over 1,800 boxes of a generic medication in the US due to complaints of broken tablets, according to the US health regulator.

As per the latest Enforcement Report by the US Food and Drug Administration (USFDA), US-based arm of Cipla is recalling 1,875 boxes of Lanthanum Carbonate chewable tablets (1000 mg, 10-count bottle) in the American market.

The medication is indicated for the treatment of high phosphate levels in the blood.

As per the USFDA, New Jersey-based Cipla USA, Inc is recalling the affected lot due to "complaints received of crushed and broken tablets".

The drug maker initiated the Class II nationwide (US) recall on October 23 this year.

As per the USFDA, a Class II recall is initiated in a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

India is the largest supplier of generic medicines with around 20 per cent share in the global supply by manufacturing 60,000 different generic brands across 60 therapeutic categories.

The products manufactured in the country are shipped to over 200 countries around the globe, with Japan, Australia, West Europe, and the US as main destinations.
Source: PTI
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ciplageneric drugrecallusfdalanthanum carbonatebroken tabletsclass ii recallhigh phosphate levels
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