General Warnings

Dr. Berne’s MSM Eye Drops Recalled for Contamination

In a precautionary move, Dr. Berne’s Whole Health Products has initiated a voluntary recall of multiple variants of its eye drops due to concerns of bacterial and fungal contamination. The recall, issued on August 26, 2023, affects Dr. Berne’s MSM Drops 5% and 15% Solution, as well as Dr. Berne’s Organic Castor Oil Eye Drops and Dr. Berne’s MSM Mist 15% Solution.

The company took this step after an FDA analysis discovered contamination in one specific lot of Dr. Berne’s MSM Drops 5% Solution, emphasizing their commitment to consumer safety.

Risk of Vision-Threatening Infections

Using the contaminated eye drops could lead to a range of issues, from minor infections to serious and even life-threatening conditions that pose a direct threat to vision. Although only two adverse events have been reported so far in connection with the recall, Dr. Berne’s Whole Health Products is leaving no stone unturned in ensuring the safety of its customers.

Recall Details

The recall encompasses all lots of Dr. Berne’s MSM Drops 5% and 15% Solution, Dr. Berne’s Organic Castor Oil Eye Drops, and Dr. Berne’s MSM Mist 15% Solution. These products, intended to serve as lubricating eye drops, come in 30 ml/1.014 oz. plastic bottles. The affected Dr. Berne’s Organic Castor Oil Eye Drops are packaged in white plastic bottles of the same size, while the Dr. Berne’s MSM Mist 15% Solution is presented in a similar white bottle. All the implicated products were made available through Dr. Berne’s webstore.

Recall Process

Dr. Berne’s Whole Health Products is taking proactive steps to ensure customer safety. The company is contacting its distributors and consumers via email to facilitate the return of the affected products. Customers who possess any of the recalled items are advised to cease using them immediately and return them to the designated return center: Sun Star Organics, located at 988 Main Street, Orange, CA 92867.

Consumer Assistance

Consumers who have queries or concerns related to this recall are encouraged to reach out to Dr. Berne’s Whole Health Products directly. They can contact the company’s customer service at (877) 239-3777 or send an email to hello@drsamberne.com. The customer service is available Monday through Friday from 9 am to 5 pm Mountain Time. Additionally, consumers should consult their healthcare provider if they have encountered any issues that could be linked to the use of these products.

Reporting Adverse Reactions

Individuals who have experienced adverse reactions or quality problems resulting from the use of the recalled products are urged to report their experiences to the FDA’s MedWatch Adverse Event Reporting program. Reports can be submitted online through the FDA’s website, or individuals can obtain a reporting form by calling 1-800-332-1088 or downloading it from the FDA’s official website. The form can then be returned via regular mail or fax.

FDA Oversight

This recall is being conducted in cooperation with the U.S. Food and Drug Administration, emphasizing the regulatory body’s role in overseeing and ensuring public safety with regards to pharmaceutical and health products.

Source: U.S. Food and Drug Administration (FDA)

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Dr. Oche Otorkpa PG Cert, MPH, PhD

Dr. Oche is a seasoned Public Health specialist who holds a post graduate certificate in Pharmacology and Therapeutics, an MPH, and a PhD both from Texila American University. He is a member of the International Society of Substance Use Professionals and a Fellow of the Royal Society for Public Health in the UK. He authored two books: "The Unseen Terrorist," published by AuthorHouse UK, and "The Night Before I Killed Addiction."
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