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.
D-0035-2024
Product summary
- Event
- Event 92952
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1744 bottles
- Official record key
drug-enforcement:D-0035-2024
Official wording
Reason: CGMP Deviations
Code information: Lot: 6666, Exp. 11/30/25
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.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations