NEW JERSEY — Health officials are warning consumers in New Jersey and across the nation about potential contamination in two brands of eye drops, which could lead to a serious and even fatal infection.
Last week, the Food and Drug Administration issued a warning to consumers not to purchase “and to immediately stop using” Dr. Berne’s MSM Drops 5 percent Solution and LightEyez MSM Eye Drops – Eye Repair.
The eye drops could potentially be contaminated with bacteria, fungus, or both, according to an Aug. 22 consumer warning. Both companies sell the drops online.
“Using contaminated eye drops could result in minor to serious vision-threatening infection which could possibly progress to a life-threatening infection,” said the FDA.
Health officials also said these products contain an active ingredient that is unapproved, and is “illegally marketed” for sale in the United States.
The FDA warning said that microbial contaminants were found in both products.
The Dr. Berne’s MSM Drops were found to have both bacterial and fungal contamination, while the LightEyez MSM Drops were found to have four different bacterial contaminants.
On Aug. 26, Dr. Berne’s issued a voluntary recall of several lubricating eye drops (see below).
The Food and Drug Administration did not indicate that this recall is connected to a deadly strain of highly drug-resistant bacterial infections from contaminated eyedrops, which has been linked to four deaths nationwide.
That particular bacteria, P. aeruginosa, was not on the list of contaminants found in the Dr. Berne’s and LightEyez products.
Health officials also said these two products also contain methylsulfonylmethane (MSM) as an active ingredient, which is not approved in the U.S. “These products are unapproved drugs and illegally marketed in the U.S.,” the FDA said. “There are no legally marketed ophthalmic drugs that contain MSM as an active ingredient.”
Dr. Berne’s Whole Health Products issued a nationwide recall of these eye drops and several others on Aug. 26. Two people reported adverse reactions to using the drops, the company said, but did not provide further details.
The Dr. Berne’s-issued recall is for all lots of MSM DROPS 5 percent and 15 percent Solution, Dr. Berne’s Organic Castor Oil Eye Drops, and Dr. Berne’s MSM MIST 15 percent Solution.
LightEyez Limited had not responded to the FDA as of last week’s warning, and does not appear to have issued any recall.
Dr. Berne’s consumers with questions about the recall can contact Dr. Berne’s Whole Health Products at (877) 239-3777 or by e-mail at [email protected] Mon-Fri 9-5 pm Mountain time.
Anyone who has quality problems, or who experiences an adverse reaction to using the eye drops, is advised to contact their physician or healthcare provider. Consumers can also report to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax:
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall comes amid a growing number of cases linked the deadly and “extensively drug-resistant” P. aeruginosa bacteria found in eye drops, which health officials as EzriCare Artificial Tears.
According to the most recent Centers for Disease Control update, 81 patients with the rare strain have been identified in 17 other states. Those states are: California, Colorado, Connecticut, Delaware, Florida, Illinois, North Carolina, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Dakota, Texas, Utah, Washington and Wisconsin.
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