FDAClass IIJuly 5, 2023

DoloEar Earache Drops recall: CGMP Deviations

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

Why was DoloEar Earache Drops recalled?

cGMP deviations

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 2423, exp. date Nov-24; 2445, exp. date Apr-25

Product
DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-001-15
Recalling firm
Homeocare Laboratories, Inc.
Quantity
12,850 tottles
Distribution
Product was distributed USA nationwide.
Recall date
July 5, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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