DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55...
FDA Recall #D-0884-2023 — Class II — June 5, 2023
Product Description
DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-001-15
Reason for Recall
cGMP deviations
Recalling Firm
Homeocare Laboratories, Inc. — Yonkers, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
12,850 tottles
Distribution
Product was distributed USA nationwide.
Code Information
Lot # 2423, exp. date Nov-24; 2445, exp. date Apr-25
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated