D-0494-2017 Class I Terminated

Recalled by Jeffreys Drug Store — Canonsburg, PA

Recall Details

Product Type
Drugs
Report Date
March 8, 2017
Initiation Date
November 23, 2016
Termination Date
October 29, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9 - 30 day scripts

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.

Distribution Pattern

PA

Code Information

Lot #: 071116-103323, Exp. Date 1/7/2017