Drug Enforcement D-0380-2025

cGMP deviations

Status

Ongoing

Classification

Class II

Report Date

April 30, 2025

Termination Date

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Product Information

Product description
DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-401-15
Product quantity
27,648 bottles
Reason for recall
cGMP deviations
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
DE

Location & Firm

Recalling firm
Pharmadel, LLC
Address
650 Centerpoint Blvd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0380-2025
Event ID
96639
Recall initiation date
April 15, 2025
Center classification date
April 21, 2025
Code info
Lot, expiry: DEE-01, EXP: OCT 26; DEE-02 EXP: FEB 27
More code info
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