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.
The USFDA has classified it as a Class-II recall.