Drug product
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
D-0680-2017
Product summary
- Event
- Event 77110
- Status
- Terminated
- Classification
- Class III
- Quantity
- 476 cartons (10x10 blister packs per carton)
- Official record key
drug-enforcement:D-0680-2017
Official wording
Reason: Supotent: Out of Specification result for assay test during routine stability testing.
Code information: Lot #0111593, Exp. 05/2017
Distribution pattern: CO, LA and OH.
Derived failure modes
-
Potency or specification failure
Out of Specification