Two major brands of dangerous eye drops have finally been recalled, a week after the Food and Drug Administration (FDA) asked distributors of 27 types of eye drops to recall them. The two brands cover eight of the 27 types. Both were supplied by Velocity Pharma LLC of New York. These types of drops are typically used for relief from dry eyes.
Consumers shouldn’t use any of the 27 affected brands.
The complete list is here.
In the two announcements, posted Nov. 1 by the FDA:
- Cardinal Health of Ohio is recalling all lots of ophthalmic products supplied to consumers by Velocity Pharma.
- Harvard Drug Group of Tennessee, which does business as Major Pharmaceutical and Rugby Laboratories, is recalling all lots of polyvinyl alcohol, 1.4% lubricating eye drops and lubricating tears eye drops (Dextran/Hypromellose, 0.1%/0.3%) supplied to consumers by Velocity Pharma.
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The FDA requested the recalls Oct. 25 after investigators found unsanitary conditions in the manufacturing facility and positive results for bacteria in samples from key parts of the facility.
The notices said both Cardinal and Harvard Drug have each received three reports of “adverse events” related to the affected products. Harvard Drug said its complaints included vision blurriness, vision loss and burning eyes.
The Cardinal products were distributed nationwide to wholesalers and retailers since Dec. 12, 2021. The Harvard products were distributed nationwide since June 1, 2021.
Consumers who have any of these products, or any of the remaining eye drops flagged by the FDA, should stop using them. The list includes products under the CVS Health, Rite Aid, Target Up&Up and Equate brands.
Both the Cardinal and Harvard notices said:
“For those patients who use these products, there is a potential risk of eye infections that could result in partial vision loss of blindness. These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because drug applied to the eyes bypass some of the body’s natural defenses.”
In recent days, after companies initially refused to do a recall, the FDA warned that the contaminated eye drops that could cause blindness. Besides the ones recalled, the other affected products are sold under brands including CVS Health, Rite Aid, Target Up&Up, Equate (Walmart.) Most of the retailers involved have agreed to pull the products off shelves and websites, but that doesn’t help people who already purchased them.
The warning and recalls follow three other recalls of eye drops this year, stemming from drug-resistant bacteria. One was linked to 81 incidents, including four deaths and 14 cases of vision loss, the FDA and Centers for Disease Control and Prevention said.
This highlights two big problems:
- The need for the FDA to have authority to recall unsafe prescriptions and over-the-counter medications when companies — for example, this eye drop manufacturer — refuse to cooperate in a timely fashion. Over the last few years, Congress has considered at least two bills — the Protecting Americans from Unsafe Drugs Act and the Recall Unsafe Drugs Act, now part of another bill — that would give the FDA mandatory recall authority. Neither has passed yet.The FDA can mandate recalls for only a few types of products, including medical devices, vaccines, nicotine products and products made of human cells.
- The need to address antibiotic overuse to protect people against a variety of avoidable problems. Antibiotic overuse is a primary driver of drug-resistant bacteria — the cause of the most serious eye drop contamination earlier this year the FDA said.
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Consumer Watchdog, U.S. PIRG Education Fund
Teresa directs the Consumer Watchdog office, which looks out for consumers’ health, safety and financial security. Previously, she worked as a journalist covering consumer issues and personal finance for two decades for Ohio’s largest daily newspaper. She received dozens of state and national journalism awards, including Best Columnist in Ohio, a National Headliner Award for coverage of the 2008-09 financial crisis, and a journalism public service award for exposing improper billing practices by Verizon that affected 15 million customers nationwide. Teresa and her husband live in Greater Cleveland and have two sons. She enjoys biking, house projects and music, and serves on her church missions team and stewardship board.