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United States (U.S.) Food and Drug Administration (FDA) Recall of Contaminated Eye Drops

November 1, 2023 | by sau1admin

PA Office of Developmental Programs logo above text that reads Pennsylvania Department of Human Services Office of Developmental Programs.

The Office of Developmental Programs (ODP) is sharing this important information about eye drops from the U.S. FDA. Eye drops from the 26 products listed below in the FDA MedWatch warning should not be used.

US Food and Drug Administration MedWatch Health Provider Team Safety Information and Adverse Event Reporting Program

TOPIC: FDA is warning consumers not to purchase and to immediately stop using 26 over-the-counter eye drop products due to the potential risk of eye infections that could result in partial vision loss or blindness.


AUDIENCE: Consumer, Health Professional, Ophthalmology

ISSUE: FDA recommended the manufacturer of these products recall all lots on October 25, 2023, after agency investigators found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility.

CVS, Rite Aid and Target are removing the products from their store shelves and websites. Products branded as Leader, Rugby and Velocity may still be available to purchase in stores and online and should not be purchased.

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

Risk Statement: Using contaminated eye drops could result in minor to serious vision-threatening infection which could possibly progress to a life-threatening infection. To date, there have been no reports of adverse events related to this recall.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: These products are used as a lubricating eye drops.

RECOMMENDATIONS:

Health professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report online.
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

Read Recall Button

Follow us on Twitter at @FDAMedWatch

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