FDA recall D-0494-2017

Product

Domperidone capsules 10 mg, compounded, dispensed in 60, 90, and 360 count bottles, Jeffreys Drug Store 1 North Central Ave. Canonsburg, PA

Reason for recall

Marketed without an approved NDA/ANDA for which safety and efficacy has not been established.

Distribution

PA

Key facts

Status

Terminated

Initiation date

2016-11-23

Report date

2017-03-08

Termination date

2018-10-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Canonsburg, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0494-2017