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

FDA recall notice · announced March 8, 2017 · Jeffreys Drug Store

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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.

Notes

Distribution: PA
Lot/code information: Lot #: 071116-103323, Exp. Date 1/7/2017
Quantity: 9 - 30 day scripts
Status: Terminated
Products in this recall event:
- Domperidone capsules 10 mg, compounded, dispensed in 60, 90, and 360 count bottles, Jeffreys Drug Store 1 North Central Ave. Canonsburg, PA (D-0494-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.