Riomet (Metformin Hydrochloride Oral Solution) Recalled
Samples of the diabetes medication were contaminated.
Sun Pharmaceutical Industries announced that it is voluntarily recalling two lots of Riomet (metformin hydrochloride oral solution). The drug was found to be contaminated with Scopulariopsis brevicaulis.
Riomet is indicated to treat type 2 diabetes in adults and children over the age of 10. It is packaged in 118 mL (4 fl oz) and 473 mL (16 fl oz) bottles. The affected lots are products with the NDC Code 10631-206-01 Lot A160031A, Exp.: 01/2018, and NDC 10631-206-02 Lot: A160031B, Exp.: 01/2018. The lots were distributed nationwide.
The contamination was discovered during sample preparation for the Antimicrobial Preservative Effectiveness Testing (AMPET), which was performed as part of the 12-month stability study interval.
Using the contaminated drugs could result in a risk of infection, especially in immunocompromised patients. The most likely route of infection is through the respiratory tract, where it could cause pneumonia, sinusitis, and other infections. Sun Pharmaceuticals has so far not received any adverse events related to the recall.
Adverse reactions or quality problems experienced with this drug may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
