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
Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here
Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd