Drug & medication recalls High risk

Jeffreys Drug Store recalls Domperidone capsules 10 mg, compounded, dispensed in 60, 90, and 360 count bottles, Jeffreys Drug Store 1 North Central…

Recall date
November 23, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0494-2017
FDA classification
Class I
Brand / firm
Jeffreys Drug Store
Sold / distributed
PA

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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

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