Lupin has initiated a nationwide voluntary recall of pneumonia antibiotic in the US after a complaint of metal piece in the bottle was received. In a recent enforcement report, the US Food and Drug Administration (USFDA) said Lupin Pharmaceuticals Inc., the US arm of Mumbai-based Lupin, has recalled 18,408 bottles of Cefdinir, 250mg/5ml powder for oral suspension in 60-ml bottle manufactured at Lupin’s Mandideep plant in Madhya Pradesh. Cefdinir is an antibiotic used to treat pneumonia, otitis media, strep throat, and cellulitis.
The reason for the recall is given as a complaint received of metal piece identified in the product bottle prior to the reconstitution. The ongoing Class-II recall was initiated on May 23. The products have an expiry date of November 2020.
The company also initiated a voluntary recall of Amikacin Sulfate Injection, 1g/4ml, with an expiry of October 2019, and Prochlorperazine Edisylate Injection, 10 mg/2ml, with an expiry of April 2020. These drug products are manufactured by Emcure Pharmaceuticals and distributed by Heritage. The voluntary recall is being initiated due to microbial growth having been detected, which may indicate a lack of sterility in the other sub-lots. Non-sterile injectable products that are intended to be sterile may result in a site-specific or systemic infection, which may cause hospitalization or death. Heritage has not received adverse event reports related to this event.