Class II · Moderate risk Terminated
Donepezil HCl Tablets
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Donepezil HCl tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Supotent: Out of Specification result for assay test during routine stability testing.
What was recalled
Donepezil HCl tablets, 10mg, packaged in 10x10 blister packs per carton (100 Unit Dose) container, Rx only, Manufactured by Sandoz, Inc., 506 Carnegie Center, Suite 400, Princeton, NJ 08805, Distributed by: McKesson Packaging Services, 7101 Weddington Rd, Concord, NC 28027, NDC 63739-678-10
- Recalling firm
- Mckesson Packaging Services
- NDC code
- 63739-678-10
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0680-2017
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Donepezil recalls
See all
Class II · Moderate risk Terminated
Donepezil HCl Tablets
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class III · Low risk Terminated
Donepezil HCL Tablets
Reason Subpotent
Class II · Moderate risk Terminated
Namzaric
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk Terminated
Donepezil Hydrochloride Tablets
Reason Subpotent Drug: out of specification results for assay test.
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