The company is recalling the drug, Cefdinir, due to “complaint received of metal piece identified in the product bottle prior to the reconstitution”
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, 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 (US FDA).
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.
The US FDA 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.