The Riomet has been found to be contaminated with microbe, Scopulariopsis brevicaulis.
New Delhi, November 27, 2017: Sun Pharma on Friday said its US- based subsidiary is recalling two lots of diabetes drug Riomet due to microbial contamination.
Sun Pharmaceutical Industries Inc (SPII), a wholly owned subsidiary of the company, is voluntarily recalling two lots of Riomet (Metformin Hydrochloride Oral Solution), to the retail level, the Mumbai-based drug major said in a statement.
The product is manufactured for SPII by a contract manufacturer, it added.
The Riomet has been found to be contaminated with microbe, Scopulariopsis brevicaulis according to economictimes.indiatimes.com.
The contamination was discovered during sample preparation for the antimicrobial preservative effectiveness testing (AMPET) being performed as part of the 12 month stability study interval, Sun Pharma said.
According to the reports published in economictimes.indiatimes.com use of contaminated Riomet potentially could result in a risk of infection, especially in the immunocompromised patient.
“To date, SPII has not received any reports of adverse events related to this recall,” the company said.
Riomet is indicated to treat type 2 diabetes mellitus in adult and children age 10 and above.
- This specialized division empowers patients with neurological disorders to reclaim their mobility through a…
SSI Mantra Robotic System performs a successful urology procedure on a one-year-old infant with a…
Ghaziabad, April 22, 2024: In order to strengthen the safety and wellbeing of people, Manipal Hospital…
DKMS EMPHASIZES ITS COMMITMENT TO BLOOD CANCER RESEARCH, SUPPORTS YOUNG SCIENTISTS, AND RECOGNIZES OUTSTANDING RESEARCH…
Dr. Reddy's has launched Nerivio® in Germany through its step-down subsidiary betapharm To be followed…
Hyderabad, April 13, 2024: Ankura Hospital for Women and Children is proud to announce a remarkable medical…