Medicine recalls
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| The United States: Kilitch Healthcare India Limited issues voluntary nationwide recall of various eye drops for potential safety reasons |
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The US Food and Drug Administration (FDA) announces that Kilitch Healthcare India Limited (the manufacturer) is voluntarily recalling the following eye drops products to the consumer level with all lots within expiry. These products are being recalled due to potential safety concerns after FDA investigators found insanitary conditions.
The affected products are:
- CVS Health Lubricant Eye Drops 15 ml (single pack)
- CVS Health Lubricant Eye Drops 15 ml (twin pack)
- CVS Health Lubricant Gel Drops 15 ml (single pack)
- CVS Health Lubricant Gel Drops 15 ml (twin pack)
- CVS Health Multi-Action Relief Drops 15 ml
- CVS Health Lubricant Gel drops 10 ml
- CVS Health Lubricant Eye Drops 10 ml (single pack)
- CVS Health Lubricant Eye Drops 10 ml (twin pack)
- CVS Health Mild Moderate Lubricating Eye Drops 15 ml (single pack)
- Leader (Cardinal Health) Eye Irritation Relief 15 ml
- Leader (Cardinal Health) Dry Eye Relief 15 ml
- Leader (Cardinal Health) Lubricant Eye Drops 15 ml (single pack)
- Leader (Cardinal Health) Lubricant Eye Drops 15 ml (twin pack)
- Leader (Cardinal Health) Dry Eye Relief 10 ml
- Leader (Cardinal Health) Lubricant Eye Drops 10 ml
- Rugby (Harvard Drug Group) Lubricating Eye Drops 15 ml
- Rugby (Harvard Drug Group) Lubricating Tears Eye Drops 15 ml
- Rite Aid Lubricant Eye Drops 15 ml (twin pack)
- Rite Aid Lubricant Eye Drops 10 ml (twin pack)
- Rite Aid Gentle Lubricant Gel Eye Drops 15 ml
- Rite Aid Lubricant Gel Drops 15 ml
- Rite Aid Lubricating Gel Drops 10 ml
- Rite Aid Multi-Action Relief Drops 15 ml
- Target Up&Up Dry Eye Relief 15 ml
- Target Up&Up High Performance Lubricant Eye Drops 15 ml (single pack)
- Target Up&Up High Performance Lubricant Eye Drops 15 ml (twin pack)
- Velocity Pharma LLC Lubricant Eye Drop 10 ml (triple pack)
- Walmart Equate Hydration PF Lubricant Eye Drop 10 ml
For those patients who use these products, there is a potential risk of eye infections or related harm. These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses. To date, Kilitch Healthcare India Limited has not received any reports of adverse events related to this recall.
These products were distributed nationwide to wholesalers, retailers, and via the product distributor, Velocity Pharma LLC.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kilitch-healthcare-india-limited-issues-voluntary-nationwide-recall-various-eye-drops-potential
http://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-certain-eye-drops-several-major-brands-due-risk-eye
In Hong Kong, the above products are not registered pharmaceutical products. There is also no registered pharmaceutical product manufactured by Kilitch Healthcare India Limited. Related news was previously issued by FDA, and was posted on the Drug Office website on 28 Oct 2023 and 2 Nov 2023.
Ends/Thursday, Nov 16, 2023
Issued at HKT 15:30
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