Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM
Summary
The FDA issued a Class I for Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Be by Dr. Berne's Whole Health Products. Reason: Non-Sterility.
Details
Source
Drug Recall
External ID
D-0037-2024
Action Date
2023-10-11
Status
Ongoing
Category
drug
Product Description
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.
Lot/Code Info: Lot: 6786, Exp: 03/31/25
Quantity Affected: N/A
Reason for Recall
Non-Sterility
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-26
Company
Tesuque, NM
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 59 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Dr. Berne's Whole Health Products has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Dr. Berne's Whole Health Products) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Dr. Berne's Whole Health Products have FDA actions?
Dr. Berne's Whole Health Products has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0037-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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