November 2016 FDA Recall Drug by Jeffreys Drug Store
D-0494-2017 - Marketed without an approved NDA/ANDA for which safety and efficacy has not been established.

This Class I drug recall was voluntarily initiated by Jeffreys Drug Store on November 23, 2016 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda for which safety and efficacy has not been established.. The product was distributed in PA and the recall is currently terminated.

Recall Number: D-0494-2017

Reason for Recall
Marketed without an approved NDA/ANDA for which safety and efficacy has not been established.
Initiated
11-23-2016
Reported
03-08-2017
Quantity
9 - 30 day scripts

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75741
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Jeffreys Drug Store
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
PA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-29-2018
Product Description About Product Description
Full technical description of the product.
Domperidone capsules 10 mg, compounded, dispensed in 60, 90, and 360 count bottles, Jeffreys Drug Store 1 North Central Ave. Canonsburg, PA

Batch or Lot Expiration Information

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