Dr. Berne's MSM MIST 15% Topical Spray Recalled for Manufacturing Deviations
Dr. Berne's Whole Health Products has voluntarily recalled Dr. Berne's MSM MIST 15% Solution (30 mL bottles) due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. The recall affects 795 bottles distributed nationwide and internationally.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II drug recall with no reported illnesses, injuries, or deaths. The recall addresses manufacturing process deviations without a specific identified contamination or hazard. This is scored as Moderate due to the voluntary, precautionary nature and absence of reported safety incidents.
Plain-English summary
Dr. Berne's Whole Health Products has issued a voluntary recall of Dr. Berne's MSM MIST 15% Solution in 30 mL (1.014 oz) bottles. The recall was initiated on August 26, 2023, and covers 795 bottles.
The recall was issued due to identified Current Good Manufacturing Practice (CGMP) deviations. CGMP violations indicate that the product was not manufactured under the required standards for quality control and safety processes.
The affected product has been distributed nationwide in the United States as well as internationally to the United Kingdom, 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, and Barbados. The recalled lot numbers are 6617 (expires 05/24), 6623 (expires 06/24), 6646 (expires 07/24), 6675 (expires 09/24), and 6716 (expires 11/24).
Consumers who have purchased this product should stop using it and contact Dr. Berne's Whole Health Products at [email protected] for further instructions regarding return or disposal.
The recalled product
- 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, [email protected].
- Manufacturer
- Dr. Berne's Whole Health Products
- Category
- Drug — Topical Solution
- Hazard
- Affected units
- 795
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Lot: 6617
- Exp. 05/24
- 6623
- Exp 06/24
- 6646
- Exp 07/24
- 6675
- Exp 09/24
- 6716
- Exp 11/24.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Dr. Berne's Whole Health Products under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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