January 27, 2017
Sandoz Inc is voluntarily recalling more than 10,000 bottles of Donepezil Hydrochloride Tablets, 10 mg.
The US Food and Drug Administration (FDA) Enforcement Report for the week of January 25, 2017, lists the reason for the recall as “Subpotent Drug: out of specification results for assay test.”
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The recall affects 10,200 30-count bottles (lot number: FJ6599, Exp 05/17) and 300 1000-count bottles (lot number: FJ6600, Exp 05/17) of the Alzheimer’s disease medication. The impacted drugs were distributed nationwide.
The National Drug Codes of the recalled 30-count and 1000-count bottles are 0781-5275-31 and 0781-5275-10, respectively.
The recall was initiated on December 13, 2016. It is currently ongoing.
The FDA classified this as a Class III recall on January 19, 2017. Class III recalls include products “that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws.”--Meredith Edwards White
Enforcement Report. US Food and Drug Administration Website. http://www.accessdata.fda.gov/scripts/ires/index.cfm. Published January 25, 2017 Accessed January 27, 2017.
Enforcement Report Definitions. US Food and Drug Administration Website. http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm181313.htm. Updated March 11, 2016. Accessed January 27, 2017.