Medicine recalls
|
| |
| The United States: Cardinal Health, Inc. issues voluntary nationwide recall of certain LEADER™ brand eye drops supplied by Velocity Pharma, LLC due to potential risk of eye infections |
| |
The US Food and Drug Administration (FDA) announces that Cardinal Health, Inc. is initiating a voluntarily recall for all lots of ophthalmic products supplied by Velocity Pharma, LLC to the consumer level. Cardinal Health, Inc. received information from FDA indicating investigators found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility. The affected products are:
- Eye Irritation Relief (polyvinyl alcohol, 0.5%, povidone, 0.6%, and tetrahydrozoline hydrochloride, 0.05%)
- Dry Eye Relief (carboxymethylcellulose sodium, 1%)
- Lubricant Eye Drops (carboxymethylcellulose sodium, 0.5%)
- Lubricant Eye Drops (carboxymethylcellulose sodium, 0.5%) 2 bottles
- Dry Eye Relief (polyethylene glycol 400, 0.4% and propylene glycol, 0.3%)
- Lubricant Eye Drops (propylene glycol, 0.6%)
For those patients who use these products, there is a potential risk of eye infections that could result in partial vision loss or 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. To date, Cardinal Health, Inc., and its subsidiaries have received reports of 3 adverse events related to these listed products. The reports of adverse events were shared with the supplier, Velocity Pharma, LLC.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cardinal-health-inc-issues-voluntary-nationwide-recall-certain-leadertm-brand-eye-drops-supplied
In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by FDA, and was posted on the Drug Office website on 28 Oct 2023.
Ends/Thursday, Nov 2, 2023
Issued at HKT 16:00
|
| |
|
