Domperidone capsules 10 mg, compounded, dispensed in 60, 90, and 360 count bottles, Jeffreys Dru...
FDA Recall #D-0494-2017 — Class I — November 23, 2016
Product Description
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.
Recalling Firm
Jeffreys Drug Store — Canonsburg, PA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
9 - 30 day scripts
Distribution
PA
Code Information
Lot #: 071116-103323, Exp. Date 1/7/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated