Drug product
Dr. Berne's MSM MIST 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, hello@drsamberne.com.
D-0034-2024
Product summary
- Event
- Event 92952
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 795 bottles
- Official record key
drug-enforcement:D-0034-2024
Official wording
Reason: CGMP Deviations
Code information: Lot: 6617, Exp. 05/24; 6623, Exp 06/24; 6646, Exp 07/24; 6675, Exp 09/24; 6716, Exp 11/24.
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