Medicine recalls
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| The United States: Alcon Laboratories issues voluntary nationwide recall of one lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101), due to fungal contamination |
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The United States Food and Drug Administration (FDA) announces that Alcon Laboratories is voluntarily recalling one lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (lot number: 10101) to the consumer level due to fungal contamination. Alcon evaluated a consumer complaint of foreign material observed inside a sealed single use vial and determined the material to be fungal in nature.
Systane Lubricant Eye Drops Ultra PF is used for the temporary relief of burning and irritation in persons experiencing dry eye symptoms and is packaged in a cardboard carton containing 25 sterile, single-use LDPE plastic vials of preservative free solution for ophthalmic use (NDC 0065-1432-06, UPC 300651432060). The affected Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count is limited to lot number 10101, expiration date 2025/09.
Fungal contamination of an ophthalmic product is known to potentially cause eye infections. If an infection occurs, it may be vision-threatening, and in very rare cases potentially life-threatening in immunocompromised patients. To date, Alcon Laboratories has not received any reports of adverse events related to this recall.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/alcon-laboratories-issues-voluntary-nationwide-recall-one-1-lot-systane-lubricant-eye-drops-ultra-pf
In Hong Kong, Systane Ultra Lubricant Eye Drops Preservative Free (HK-61280) is a pharmaceutical product registered by Alcon Hong Kong Limited (Alcon). It is an over-the-counter medicine. As confirmed by Alcon, the manufacturer of the product recalled in the United States is different from the Hong Kong registered product, and the affected lot has not been imported into Hong Kong.
Ends/Tuesday, Dec 24, 2024
Issued at HKT 16:00
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