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Diabetes Medication Recalled


December 09, 2016

Ascend Laboratories LLC is recalling 1739 1000-count bottles of Metformin Hydrochloride Tablets, USP 500 mg, due to the presence of foreign tablets.

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According to the US Food and Drug Administration (FDA) Enforcement Report for the week of December 7, amlodipine tablets were discovered in certain bottles of the prescription type 2 diabetes medication. The recall affects bottles distributed in Alabama, Florida, Georgia, South Carolina, and Tennessee with the following code information:

  • Lot #6121056, exp 5/2019

This ongoing recall was first initiated by Ascend Laboratories on November 2. The FDA classified it as a Class II recall on November 29. A Class II recall involves products that “might cause a temporary health problem, or pose only a slight threat of a serious nature,” according to the FDA Enforcement Report Definitions page.

The medication was manufactured by Alkem Laboratories Ltd in Mumbai, India, and distributed by Ascend Laboratories in Montvale, NJ.—Meredith Edwards White

References

http://www.accessdata.fda.gov/scripts/ires/index.cfm

http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm181313.htm

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