Believe it or not, medications are recalled on a daily basis for numerous reasons. Recalls can range from minor to life-threatening incidents if not immediately and appropriately taken care of.
What is Riomet indicated for?
Riomet is indicated (in addition to diet and exercise) to improve blood sugar control in adults and children 10 years of age and older with type 2 diabetes.
Why was Riomet recalled?
Riomet has been found to be contaminated with a type of fungus known as Scopulariopsis brevicaulis. If injected, this fungus can cause an increased risk of infection, especially in those who are immunocompromised.
Have there been any adverse event reports to Sun Pharmaceutical Industries from patients?
No. At this time, Sun Pharmaceuticals has not received any reports of adverse events associated with this recall.
Which Riomet products were recalled?
According to the FDA’s Announcement, the affected products were distributed nationwide to wholesale customers in the United States.
This recall will affect the following:
- Drug: Riomet 500 mg/5 ml
- Manufacturer: Sun Pharmaceuticals Industries (but the recalled product was actually being made by a contract manufacturer)
- Bottle size: 118 ml (4 ounce) bottle, and 473 ml (16 ounce) bottle
- National Drug Codes: 10631-206-01 (lot A160031) and 10631-206-02 (A160031B)
What has been done to alert those who may be affected?
On April 18, 2017, Sun Pharmaceutical Industries notified its wholesale customers through its 3rd party recall coordinator (Inmar Inc.) and has arranged for the return via prepaid FedEx Ground shipping of all recalled products.
What do I do if I think I have a recalled package?
Consumers who have purchased this product should not open the package or use the contents. Instead, they should return the product to the location of purchase for a full refund, or call Sun Pharmaceuticals at 1-800-406-7984. You should contact your physician or healthcare provider if you have experienced any problems that may be related to taking or using these drug products.
Always inspect your medications, including all parts of the packaging and devices. If you ever notice your medication doesn’t look or smell right, contact the manufacturer or ask your pharmacist for more information. You can also notify the FDA’s MedWatch Reporting Program as they can conduct further necessary investigations.
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