Drug & medication recalls Moderate risk

DoloEar Earache Drops recalled over manufacturing violations

Recall date
June 5, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Homeocare Laboratories, Inc. recalls DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-001-15
Recall number
D-0884-2023
FDA classification
Class II
Brand / firm
Homeocare Laboratories, Inc.
Sold / distributed
Product was distributed USA nationwide.

Why it was recalled

cGMP deviations

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-001-15

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