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Lupin recalls over 18000 bottles of Cefdinir for Oral Suspension in US


Lupin recalls over 18000 bottles of Cefdinir for Oral Suspension in US

Cefdinir is used to treat a wide variety of bacterial infections. This medication is known as a cephalosporin antibiotic. It works by stopping the growth of bacteria.

New Delhi: Drug major Lupin is recalling over 18,000 bottles of Cefdinir for Oral Suspension, used to treat bacterial infections, from the US market. Lupin Pharmaceuticals Inc, an American subsidiary of the Mumbai-based company, is recalling the lot due to “complaint received of metal piece identified in the product bottle prior to the reconstitution”, as per the latest Enforcement Report of the US Food and Drug Administration (USFDA).

The company is recalling 18,408 (60 ml) bottles, it added.

The impacted lot has been manufactured by Lupin’s Mandideep manufacturing facility for Baltimore (Maryland) based Lupin Pharmaceuticals Inc.

Also Read: Japanese regulator PMDA completes inspection of Lupin Mandideep facility unit, no major observations

The USFDA has classified it as a Class-II recall, which is initiated in a “situation in which 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”.

In January this year, the company had announced recall of 2,87,784 bottles of Cefdinir for Oral Suspension in the US for CGMP (Current Good Manufacturing Practice) deviations.

Cefdinir is used to treat a wide variety of bacterial infections. This medication is known as a cephalosporin antibiotic. It works by stopping the growth of bacteria.

Also Read: Lupin recalls 43860 bottles of Moxifloxacin Ophthalmic solution in US over impurities

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Source: PTI
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