FDA recall D-0680-2017

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

Reason for recall

Supotent: Out of Specification result for assay test during routine stability testing.

Distribution

CO, LA and OH.

Key facts

Status

Terminated

Initiation date

2017-01-04

Report date

2017-05-03

Termination date

2017-08-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Concord, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0680-2017