Medicine recalls
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| The United States: Sun Pharmaceutical Industries Inc. Issues Voluntary Nationwide Recall of Riomet® (Metformin Hydrochloride Oral Solution) Manufactured by a Contract Manufacturer due to Microbial Contamination |
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The U.S. Food and Drug Administration (FDA) is alerting consumers 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm586452.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Saturday, Nov 25, 2017
Issued at HKT 12:00
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