Drug Enforcement D-0884-2023

cGMP deviations

Status

Terminated

Classification

Class II

Report Date

July 5, 2023

Termination Date

September 16, 2024

Product Information

Product description
DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-001-15
Product quantity
12,850 tottles
Reason for recall
cGMP deviations
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Product was distributed USA nationwide.

Location & Firm

Recalling firm
Homeocare Laboratories, Inc.
Address
7 Odell Plz Ste 142-146, N/A

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

Codes & Dates

Recall number
D-0884-2023
Event ID
92453
Recall initiation date
June 5, 2023
Center classification date
June 26, 2023
Code info
Lot # 2423, exp. date Nov-24; 2445, exp. date Apr-25
More code info
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