DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-401-1
Summary
The FDA issued a Class II for DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL), Distributed by: Pharmade by Pharmadel, LLC. Reason: cGMP deviations.
Details
Source
Drug Recall
External ID
D-0380-2025
Action Date
2025-04-30
Status
Terminated
Category
drug
Product Description
DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-401-15
Lot/Code Info: Lot, expiry: DEE-01, EXP: OCT 26; DEE-02 EXP: FEB 27
Quantity Affected: 27,648 bottles
Reason for Recall
cGMP deviations
Distribution
DE
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-15
Company
Historic New Castle, DE
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 56 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Pharmadel, LLC has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Pharmadel, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Pharmadel, LLC have FDA actions?
Pharmadel, LLC has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0380-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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