Recalls / Class II
Class IID-0033-2024
Product
Dr. Berne's MSM DROPS 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, hello@drsamberne.com, UPC 00854582001036
- Affected lot / code info
- Lots: 6486, Exp: 11/23; 6536, Exp: 01/24; 6549, Exp: 02/24; 6561, Exp: 03/24; 6623, Exp: 06/24; 6630, Exp: 06/24; 6646, Exp: 07/24; 6675, Exp: 09/24; 6686, Exp: 09/24; 6695, Exp: 10/24; 6738, Exp: 11/24; 6767, Exp: 01/25; 6787, Exp: 03/25; 6799, Exp: 04/25; 6832 Exp: 05/25; 6844, Exp: 05/25; 6857, Exp: 06/25; 6888, Exp: 07/25.
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
- 6060 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-0033-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.