FDA recall D-0035-2024

Dr. Berne's Whole Health Products · Class II · drug

Product

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.

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.

Key facts

Status
Ongoing
Initiation date
2023-08-26
Report date
2023-10-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tesuque, NM, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0035-2024