PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: March 8, 2017 Initiated: November 23, 2016 #D-0494-2017

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.

Details

Recalling Firm
Jeffreys Drug Store
Units Affected
9 - 30 day scripts
Distribution
PA
Location
Canonsburg, PA

Frequently Asked Questions

What product was recalled?
Domperidone capsules 10 mg, compounded, dispensed in 60, 90, and 360 count bottles, Jeffreys Drug Store 1 North Central Ave. Canonsburg, PA. Recalled by Jeffreys Drug Store. Units affected: 9 - 30 day scripts.
Why was this product recalled?
Marketed without an approved NDA/ANDA for which safety and efficacy has not been established.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 8, 2017. Severity: Critical. Recall number: D-0494-2017.