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Recall Observatory FDA recall evidence

Drug product

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

November 23, 2016

Class I

Product summary

Firm
Jeffreys Drug Store
Event
Event 75741
Status
Terminated
Classification
Class I
Quantity
9 - 30 day scripts
Official record key
drug-enforcement:D-0494-2017

Official wording

Reason: Marketed without an approved NDA/ANDA for which safety and efficacy has not been established.

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

Distribution pattern: PA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed without an approved NDA/ANDA for which safety and efficacy has not been established.