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Sun Pharma recalls two lots of Riomet from market due to microbial contamination

our Bureau, Mumbai
Friday, November 24, 2017, 20:50 Hrs  [IST]

Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. 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 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 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 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 labelled as Riomet containing the specific Lot and Exp. dates mentioned above. This product was distributed nationwide to wholesale customers.

According to a SPII press release, on April 18, 2017, the company 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 which has been recalled should stop using and return it to place of purchase, discard and/or contact their doctor.

 

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