Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Supotent: Out of Specification result for assay test during routine stability testing.
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
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.
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Reason Subpotent
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Subpotent Drug: out of specification results for assay test.
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.