Drug Enforcement D-0035-2024

CGMP Deviations

Status

Ongoing

Classification

Class II

Report Date

October 11, 2023

Termination Date

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Product Information

Product description
Dr. Berne's Organic Castor Oil Eye Drops, Net WT 30 mL/1 fl oz bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, hello@drsamberne.com, Certified Organic by Organic Certifiers.
Product quantity
1744 bottles
Reason for recall
CGMP Deviations
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide and UK, Canada, Italy, India, Australia, Germany, Switzerland, Singapore, Netherlands, Ireland, South Korea, Belgium, Norway, Saudi- Arabia, Slovenia, Malta, Israel, Sweden, Latvia, Portugal, Hong Kong, Kuwait, Romania, South Africa, Thailand, Zambia, France, Finland, Mauritius, Barbados.

Location & Firm

Recalling firm
Dr. Berne's Whole Health Products
Address
174 Tesuque Village Rd Unit 458, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0035-2024
Event ID
92952
Recall initiation date
August 26, 2023
Center classification date
October 4, 2023
Code info
Lot: 6666, Exp. 11/30/25
More code info
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