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Loose Tamper-Evident Rings Prompt FDA Warning

The agency says the issue will require a change in the packaging design.

The FDA is warning about eye drop bottles that have loose plastic safety seals or tamper-evident rings below the bottle cap that may fall onto the eye when the product is used.

Also known as a collar, or band, these should stay connected to the bottle neck. However, some eye drop bottles are losing the safety seals or rings when consumers tilt or squeeze the bottle to place eye drops into their eyes. The situation presents a safety risk as it may cause eye injuries.

The FDA is in the process of identifying all relevant products and will require a change in the packaging design.

Six adverse events associated with loose safety seals on eye drop bottles have been reported to the agency.

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