On November 27, 2017, Sun Pharmaceutical Industries recalled two lots of Riomet (Metformin Hydrochloride Oral Solution), which were found to be contaminated with Scopulariopsis brevicaulis, a mold found in soil that has caused deep fungal infections resistant to broad-spectrum antifungal agents. Use of the affected Riomet potentially could result in infection, especially in the immunocompromised patient. The most plausible portal of entry of Scopulariopsis brevicaulis is the respiratory tract, where it may cause pneumonia, sinusitis, and disseminated infections.
The affected Riomet includes product with NDC Code 10631-206-01 Lot A160031A, Exp.: 01/2018, and NDC 10631-206-02 Lot: A160031B, Exp.: 01/2018.
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.
Riomet (Metformin Hydrochloride Oral Solution) is indicated to treat type 2 diabetes mellitus in adults and children age 10 and above. Riomet is packaged in 118 mL (4 fl. oz.) and 473 mL (16 fl. oz.) bottles.
See the FDA Safety Alert
See the Recall
See also Medical Law Perspectives Report: Diabetes and Its Complications: Malpractice and Other Liability Issues
See also Medical Law Perspectives Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication