Recall of Riomet

PUBLISHED: Nov 27, 2017
Relevant to: Ambulatory Care, Critical Access Hospitals, Home Health, Hospitals, Long Term Care, Medical Office/Clinic, Pharmacies

Sun Pharmaceutical Industries is recalling two lots of Riomet (Metformin Hydrochloride Oral Solution), which were found to be contaminated with Scopulariopsis brevicaulis. Use of the affected Riomet could potentially result in a risk of 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 ages 10 and above. Riomet is packaged in 118 mL (4 fl. oz.) and 473 mL (16 fl. oz.) bottles.

On April 18, 2017, SPII notified its wholesale customers through its 3rd party Recall Coordinator (Inmar Inc.) via FedEx standard overnight shipping and has arranged for the return via prepaid FedEx Ground shipping of all recalled products. Consumers that have Riomet (Metformin Hydrochloride Oral Solution) which has been recalled should stop using and return it to the place of purchase, discard, and/or contact their doctor.

Consumers with questions regarding this recall can contact SPII by calling 1-800-406-7984, Monday through Friday between 8:00 am to 5:00 pm EST or emailing drug.safetyUSA@sunpharma.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

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