Dr. Berne's Organic Castor Oil Eye Drops, Net WT 30 mL/1 fl oz bottle, Distributed by: Dr. Berne's Whole Health Products
Summary
The FDA issued a Class II for Dr. Berne's Organic Castor Oil Eye Drops, Net WT 30 mL/1 fl oz bottle, Distribut by Dr. Berne's Whole Health Products. Reason: CGMP Deviations.
Details
Source
Drug Recall
External ID
D-0035-2024
Action Date
2023-10-11
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lot: 6666, Exp. 11/30/25
Quantity Affected: 1744 bottles
Reason for Recall
CGMP Deviations
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-26
Company
Tesuque, NM
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 59 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Dr. Berne's Whole Health Products has 5 FDA actions in our database, including 5 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 (Dr. Berne's Whole Health Products) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Dr. Berne's Whole Health Products have FDA actions?
Dr. Berne's Whole Health Products has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0035-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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