Recalls / Class I
Class ID-0037-2024
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, hello@drsamberne.com, UPC 00854582001111.
- Affected lot / code info
- Lot: 6786, Exp: 03/31/25
Why it was recalled
Non-Sterility
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
- N/A
- 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-0037-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.