Through the FDA, Dr. Berne’s Whole Health has issued a recall of their eye drops. Dr. Berne’s Organic Castor Oil Eye Drops, MSM DROPS solution, and MSM MIST solution may be contaminated with fungus and bacteria that cause serious infections. Upon inspection, MSM drops 5% were found to be contaminated, and out of an abundance of caution, Dr. Berne’s Whole Health has decided to do a massive recall of several products.
At this time, there have been two reports of adverse events related to the contaminated drops.
SUMMARY
Date of Recall:
Announced: August 26, 2023
Public Notification: August 26, 2023
Name(s) of Drug:
MSM 5% Solution Eye Drops
MSM 15% Solution Eye Drops
Castor Oil Eye Drops
MSMS MIST Drops 5% Solution
Company Name:
Dr. Berne’s Whole Health Products
Manufacturer: Sun Star Organics
Drug Indication:
Dry Eyes
Product Description
The eye drops are packaged in 30mL/1oz bottles distributed in individual boxes. Each bottle and container are individually labeled with the brand name, product name, and dosage. Products were sold at www.drsamberne.com and www.amazon.com.
Reason for Recall
A random inspection of the drops found that one lot of the MSM 5% drops were contaminated with fungi and bacteria that may cause severe eye infections and damage. So far, two reports of adverse events related to the contaminated eye drops have been reported.
Impacts
Consumers who continue using the drops could contract serious, life-threatening infections that may lead to blindness. Symptoms of eye infection include:
- Pain
- Eye Discharge
- Blurred Vision
- Light Sensitivity
- Watery Eyes
- Red Eyes
- Itchy
- Teary Eyes
- Blindness
Lot Information
Consumers should locate any Dr. Berne’s products they currently own. At this time, all lots of Dr. Berne’s eye drop solutions listed are being recalled. If your medication is on the list, you must take additional steps to participate in the recall procedures.
| Product Description | Lot Number |
| MSM DROPS 5% Solution | All Lots |
| MSM DROPS 15% Solution | All Lots |
| Organic Castor Oil Eye Drops | All Lots |
| MSM MIST 15% Solution | All Lots |
Have you found that your medication is part of the recall? Here’s what you should do:
Consumers
- Call your doctor right away. Ask for a new prescription or recommendation to replace your recalled medication and report any changes in your symptoms.
- Monitor your health for any adverse symptoms and notify your physician if any concerns are noted.
- Consumers should contact Dr. Berne’s Whole Health Products at 1 (877) 239-37777. They are available Mon-Fri from 9:00 am to 5:00 pm (MT). You can also contact them via email at hello@drsamberne.com. All refund requests should be made to sales@sunstarorganics.com. Products may be returned to Sun Star Organics, 988 Main Street, Orange, CA 92867.
- If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
Retailer
- Examine all inventory and remove stock affected by the recall immediately.
- Contact Dr. Berne’s Whole Health Products at 1 (877) 239-37777, or you can utilize hello@drsamberne.com to contact them via email. Returns and refunds can be initiated through sales@sunstarorganics.com. Notify them of any recalled batches that have already been sold to consumers.
- Notify affected consumers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
Wholesaler
- Examine all inventory and remove stock affected by the recall immediately.
- Contact Dr. Berne’s Whole Health Products at 1 (877) 239-37777, or you can utilize hello@drsamberne.com to contact them via email. Wholesalers can initiate returns and refunds initiated through sales@sunstarorganics.com.
- Notify the manufacturer of recalled batches already shipped to retailers.
- Notify affected retailers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
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Tammy McKinney, RN, creator of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or contact her directly on LinkedIn!