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MedWatch - The FDA Safety Information and Adverse Event Reporting Program
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TOPIC: Dr. Berne’s MSM Drops 5% and 15% Solution Eye Drops by Dr. Berne's Whole Health Products: Recall - Due to Bacterial and Fungal Contamination
AUDIENCE: Consumer, Health Professional, Ophthalmology
ISSUE: Dr. Berne’s Whole Health Products is recalling all lots of MSM DROPS 5% 15% Solution, Dr. Berne’s Organic Castor Oil Eye Drops and Dr. Berne’s MSM MIST 15% Solution because FDA analysis has found one lot (lot 6786) of Dr. Berne's MSM DROPS 5% Solution to fail sterility with both bacterial and fungal contamination found in the product. Out of an abundance of caution, Dr. Berne's is recalling all other lots of the 5% and 15% strengths of MSM Solution and all lots of Dr. Berne’s Organic Castor Oil Eye Drops and Dr. Berne’s MSM MIST 15% Solution.
Risk Statement: Using contaminated eye drops could result in minor to serious vision-threatening infection which could possibly progress to a life-threatening infection. To date, Dr. Berne’s has received 2 reports of adverse events related to this recall.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: These products are used as a lubricating eye drops.
RECOMMENDATIONS:
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Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.
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Consumers/distributors/retailers that have product which is being recalled should stop using and return to the company Sun Star Organics.
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Consumers with questions regarding this recall can contact Dr. Berne’s Whole Health Products.
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Health professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online.
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Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.
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