Eyedrop recall for US people

[Ausmumof3]

https://www.npr.org/2023/10/29/1209279307/fda-eyedrops-contamination

U.S. health officials are warning consumers to stop using more than two dozen over-the-counter eye drop products due to the potential risk of eye infection that could lead to vision loss.

The Food and Drug Administration on Friday issued the alert for 26 products from the following brands: CVS Health, Leader (Cardinal Health), Rugby (Cardinal Health), Rite Aid, Target Up&Up and Velocity Pharma.

The federal regulatory agency said it recommended the manufacturers to recall of the subject products on Wednesday, after FDA investigators found bacterial contamination in critical drug production areas of a manufacturing facility.

 

 

[Arcadia]

https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-certain-eye-drops-several-major-brands-due-risk-eye#eyedrops
“

Retailer/ Label	Product	Product Information
CVS Health	Lubricant Eye Drops 15 ml (single pack)	Carboxymethylcellulose Sodium Eye Drops 0.5% w/v
	Lubricant Eye Drops 15 ml (twin pack)	Carboxymethylcellulose Sodium Eye Drops 0.5% w/v
	Lubricant Gel Drops 15 ml (single pack)	Carboxymethylcellulose Sodium Eye Drops 1% w/v
	Lubricant Gel Drops 15 ml (twin pack)	Carboxymethylcellulose Sodium Eye Drops 1% w/v
	Multi-Action Relief Drops 15 ml	Polyvinyl Alcohol 0.5% w/v & Povidone 0.6% w/v & Tetrahydrozoline Hydrochloride 0.05% Eye Drops
	Lubricating Gel drops 10 ml	Polyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops
	Lubricant Eye Drops 10 ml (single pack)	Propylene Glycol Eye Drops 0.6% w/v
	Lubricant Eye Drops 10 ml (twin pack)	Propylene Glycol Eye Drops 0.6% w/v
	Mild Moderate Lubricating Eye Drops 15 ml (single pack)	Polyethylene Glycol 400 Eye Drop '0.25% w/v
Rugby (Cardinal Health)	Lubricating Tears Eye Drops 15 ml	Hypromellose 2910-0.3% w/v & Dextran 70- 0.1% Eye Drops
	Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15 ml	Polyvinyl Alcohol Eye Drops 1.4% w/v
Leader (Cardinal Health)	Dry Eye Relief 10 ml	Polyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops
	Lubricant Eye Drops 15 ml (single pack)	Carboxymethylcellulose Sodium Eye Drops 0.5% w/v
	Lubricant Eye Drops 15 ml (twin pack)	Carboxymethylcellulose Sodium Eye Drops 0.5% w/v
	Dry Eye Relief 15 ml	Carboxymethylcellulose Sodium Eye Drops 1% w/v
	Eye Irritation Relief 15 ml	Polyvinyl Alcohol 0.5% w/v & Povidone 0.6% w/v & Tetrahydrozoline Hydrochloride 0.05% Eye Drops
Rite Aid	Lubricant Eye Drops 15 ml (twin pack)	Carboxymethylcellulose Sodium Eye Drops 0.5% w/v
	Lubricant Eye Drops 10 ml (twin pack)	Propylene Glycol Eye Drops 0.6% w/v
	Gentle Lubricant Gel Eye Drops 15 ml	Hypromellose 0.3%, Glycerin 0.2%, Dextran 70 0.1% Eye Drops
	Lubricant Gel Drops 15 ml	Carboxymethylcellulose Sodium Eye Drops 1% w/v
	Lubricating Gel Drops 10 ml	Polyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops
	Multi-Action Relief Drops 15 ml	Polyvinyl Alcohol 0.5% w/v & Povidone 0.6% w/v & Tetrahydrozoline Hydrochloride 0.05% Eye Drops
Target	Up&Up Dry Eye Relief Lubricant Eye Drops 30 ml	Polyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops
	Up&Up Extreme Relief Dry Eye 15 ml (single pack)	Polyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops
	Up&Up Extreme Relief Dry Eye 30 ml (twin pack)	Carboxymethylcellulose Sodium Eye Drops 0.5% w/v
Velocity Pharma LLC	Lubricant Eye Drop 10 ml (triple pack)	Propylene Glycol Eye Drops 0.6% w/v

 

 

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ETA:

 

Walmart	Equate Hydration PF Lubricant Eye Drop 10 ml	Polyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops

Edited October 31, 2023 by Arcadia

[kbutton]

Again?!? Thanks! This is crazy. 

[Arcadia]

https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-certain-eye-drops-several-major-brands-due-risk-eye#eyedrops
“[10/30/2023] FDA is updating the list of over-the-counter eye drop products consumers should not purchase or use to include Equate Hydration PF Lubricant Eye Drop 10 mL sold by Walmart in stores and online. Walmart is removing the product from their store shelves and website.”

[Arcadia]

More info from Cardinal Health

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cardinal-health-inc-issues-voluntary-nationwide-recall-certain-leadertm-brand-eye-drops-supplied

“To date, Cardinal Health, Inc., and its subsidiaries have received reports of three (3) adverse events related to these listed products. The reports of adverse events were shared with our supplier, Velocity Pharma, LLC.

….

These products can be identified on the outer carton labeling as follows:

Product Name	Package Description	Brand Name	NDC
Eye Irritation Relief (Polyvinyl Alcohol, 0.5%, Povidone, 0.6%, and Tetrahydrozoline Hydrochloride, 0.05%)	0.5 FL OZ bottle (15 mL)	LEADER™	70000-0087-1
Dry Eye Relief (Carboxymethylcellulose Sodium, 1%)	0.5 FL OZ bottle (15 mL)	LEADER™	70000-0089-1
Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%)	0.5 FL OZ bottle (15 mL)	LEADER™	70000-0090-1
Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%)	2 bottles, 0.5 FL OZ (15 mL) each	LEADER™	70000-0090-2 (Carton) 70000-0090-1 (Bottle)
Dry Eye Relief (Polyethylene Glycol 400, 0.4% and Propylene Glycol, 0.3%)	0.33 FL OZ bottle (10 mL)	LEADER™	70000-0088-1
Lubricant Eye Drops (Propylene Glycol, 0.6%)	0.33 FL OZ bottle (10 mL)	LEADER™	70000-0587-1

…

Consumers with questions regarding this recall can contact Sedgwick, Inc. by phone at 1-855-215-4940 (8:00am-5:00pm EST Monday through Friday) or by email at Cardinalhealth7720@sedgwick.com. Consumers who have signs or symptoms of an eye infection after using these products should talk to their health care provider or seek medical care immediately.”

[Arcadia]

More info from Harvard Drug Group

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/harvard-drug-group-llc-issues-voluntary-nationwide-recall-certain-rugbyr-laboratories-brand-eye
“Both Polyvinyl Alcohol, 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) can be identified on the outer carton labeling as follows:

Brand Name	Product Name	Package Description	NDC
Rugby®	Polyvinyl Alcohol, 1.4% Lubricating Eye Drops	0.5 oz bottle (15 mL)	0536-1325-94
Rugby®	Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%)	0.5 oz bottle (15 mL)	0536-1282-94

…

Products were distributed Nationwide starting June 1, 2021.

... Consumers should stop using the recalled eye drop products and may return any of the above listed products to the place of purchase.

Consumers with questions regarding this recall can contact Sedgwick, Inc. by phone at 1- 866-891-1981 (8:00am-5:00pm EST Monday through Friday) or by email address harvarddrug8430@sedgwick.com. Consumers who have signs or symptoms of an eye infection after using these products should talk to their health care provider or seek medical care immediately.“