- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Reason for Announcement:
Recall Reason DescriptionMicrobial Contamination (Scopulariopsis brevicaulis)
- Company Name:
- Sun Pharmaceutical Industries Ltd
- Brand Name:
Brand Name(s)Sun Pharma
- Product Description:
Product DescriptionRiomet® (Metformin Hydrochloride Oral Solution), 500 mg/5mL
Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” including its subsidiaries and/or associate companies) is voluntarily recalling two lots of Riomet® (Metformin Hydrochloride Oral Solution), 500 mg/5mL, to the retail level (Class II Recall). This product is manufactured for SPII by a contract manufacturer. The Riomet® (Metformin Hydrochloride Oral Solution) has been found to be contaminated (Scopulariopsis brevicaulis). 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.
Use of Riomet® (Metformin Hydrochloride Oral Solution) potentially could 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. To date, SPII has not received any reports of adverse events related to this recall.
Riomet® (Metformin Hydrochloride Oral Solution) is indicated to treat type 2 diabetes mellitus in adult and children age 10 and above. Riomet is packaged in 118 mL (4 fl. oz.) and 473 mL (16 fl. oz.) bottles. The affected Riomet® (Metformin Hydrochloride Oral Solution) includes product with NDC Code 10631-206-01 Lot A160031A, Exp.: 01/2018, and NDC 10631-206-02 Lot: A160031B, Exp.: 01/2018. The product can be identified by its bottle labeled as Riomet® (Metformin Hydrochloride Oral Solution) containing the specific Lot and Exp. dates mentioned above. This product was distributed nationwide to wholesale customers.
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 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.
Adverse reactions or quality problems experienced with the use of this product 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
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.