Drug Enforcement D-0882-2023

cGMP deviations

Status

Terminated

Classification

Class II

Report Date

July 5, 2023

Termination Date

September 16, 2024

Product Information

Product description
Bebelyn Colic Drops Homeopathic Remedy, 0.5 FL Oz (15 mL) bottles, distributed by Pharmadel LLC Georgetown, DE NDC 55758-036-01
Product quantity
5,956 bottles
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-0882-2023
Event ID
92453
Recall initiation date
June 5, 2023
Center classification date
June 26, 2023
Code info
Lot # 2414, exp. date Sep-24
More code info
—