Recalls / Class II
Class IID-0034-2024
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.
- Affected lot / code info
- Lot: 6617, Exp. 05/24; 6623, Exp 06/24; 6646, Exp 07/24; 6675, Exp 09/24; 6716, Exp 11/24.
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Dr. Berne's Whole Health Products
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 174 Tesuque Village Rd Unit 458, N/A, Tesuque, New Mexico 87574-2030
Distribution
- Quantity
- 795 bottles
- 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.
Timeline
- Recall initiated
- 2023-08-26
- FDA classified
- 2023-10-04
- Posted by FDA
- 2023-10-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0034-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.