MSM Nutraceuticals Recalls Dr. Berne's MSM Drops Due to Sterility Concerns
MSM Nutraceuticals is recalling 500 bottles of Dr. Berne's MSM Drops because the product lacks assurance of sterility and was not tested per USP 71.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving significant safety concerns like sterility assurance in injectable or high-risk dosage forms, even without explicit hospitalization reports in the provided text.
Plain-English summary
MSM Nutraceuticals, LLC is recalling 500 30 mL bottles of Dr. Berne's MSM DROPS 15% Solution. The product is distributed by Dr. Berne's Whole Heallth Products and was sold nationwide in the USA. The specific lot number is 1808051, with an expiration date of 01/01/22.
The recall was initiated because the product is not terminally sterilized and was not tested per USP 71, resulting in a lack of assurance of sterility. This is an FDA Class II recall, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions or a refund.
The recalled product
- Product
- Dr. Berne's MSM DROPS 15% Solution, Net Wt. 30ml/1.014 OZ, Distributed by: Dr. Berne's Whole Heallth Products, 400 Hillsboro Technology Drive, Deerfield BEach, FL 33441 SKU#182 UPC 00854582001036
- Manufacturer
- MSM Nutraceuticals, LLC
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 (2)
- Lot # 1808051
- Exp. Date 01/01/22
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by MSM Nutraceuticals, LLC 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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