Version May 2024
The FDA is alerting patients and health care providers that multiple OTC ophthalmic drop products should no longer be used or purchased 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. These findings show a potential risk of ophthalmic infections that could result in partial vision loss or blindness. Patients who have signs or symptoms of an ophthalmic infection after using these products should talk to their health care provider or seek medical care immediately. The affected products are marketed under various brand names (eg, CVS Health, Rugby, Velocity Health, etc.). The FDA has recommended that the manufacturer recall all lots of these products.
Further information, including the list of impacted products, may be found at 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
Global Pharma Healthcare has recalled all lots of EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears due to possible contamination with Verona Integron–mediated Metallo-β-lactamase– and Guiana extended-spectrum β-lactamase–producing carbapenem-resistant Pseudomonas aeruginosa. Adverse events, including ophthalmic infections, permanent vision loss, and a death with a bloodstream infection, have been reported.
More information is available at https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-ezricare-artificial-tears-due-potential-contamination and https://emergency.cdc.gov/han/2023/han00485.asp
Dry eyes: Ophthalmic: Instill 1-2 drops into eye(s) 3-4 times/day
Refer to adult dosing.
There are no adverse reactions listed in the manufacturer's labeling.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Gel, Ophthalmic, as sodium:
Refresh Liquigel: 1% (15 mL)
Refresh Optive: 1 % (10 mL)
Theratears: 1% (28 ea [DSC]) [contains calcium chloride anhydrous, magnesium chloride, potassium chloride, sodium bicarbonate, sodium chloride, sodium phosphate]
Gel, Ophthalmic, as sodium [preservative free]:
Biolle Gel Tears: 1% (1 ea)
Refresh Celluvisc: 1% (30 ea)
TheraTears Nighttime: 1% (30 ea)
Liquid, Ophthalmic, as sodium:
Sterile Lubricant: 0.7% (15 mL)
Solution, Ophthalmic [preservative free]:
Ventiva Tears Plus: 0.6% (15 mL)
Solution, Ophthalmic, as sodium:
Artificial Tears: 1% (15 mL)
GoodSense Lubricating Plus PF: 0.5% (30 ea)
Lubricating Plus Eye Drops: 0.5% (30 ea [DSC], 50 ea [DSC])
Refresh Digital: 0.5% (10 mL)
Refresh Liquigel: 1% (30 mL)
Refresh Optive: 0.5% (15 mL)
Refresh Optive Advanced: 0.5% (10 mL)
Refresh Plus: 0.5% (30 ea, 50 ea, 70 ea)
Refresh Relieva: 0.5% (10 mL)
Refresh Tears: 0.5% (15 mL, 30 mL)
Theratears: 0.25% (15 mL, 30 mL) [contains calcium chloride, magnesium chloride, potassium chloride, sodium bicarbonate, sodium chloride, sodium phosphate, monobasic monohydrate]
TheraTears Extra: 0.25% (15 mL)
Ultra Fresh: 0.5% (15 mL, 30 mL)
Generic: 0.5% (15 mL)
Solution, Ophthalmic, as sodium [preservative free]:
Biolle Tears: 0.5% (32 ea)
Lubricant Eye Drops PF: 0.5% (30 ea, 50 ea)
Refresh Digital PF: 0.5% (30 ea)
Refresh Optive Advanced PF: 0.5% (30 ea)
Refresh Optive Mega-3: 0.5% (60 ea) [nacl free]
Refresh Optive Mega-3: 0.5% (30 ea)
Refresh Optive PF: 0.5% (30 ea, 60 ea)
Refresh Plus: 0.5% (30 ea, 50 ea)
Refresh Relieva PF: 0.5% (30 ea, 10 mL)
TheraTears Extra PF: 0.25% (30 ea)
Theratears PF: 0.25% (30 ea)
Ventiva Tears: 0.5% (15 mL)
May be product dependent
Gel (Biolle Gel Tears Ophthalmic)
1% (per each): $0.30
Gel (Refresh Celluvisc Ophthalmic)
1% (per each): $0.44
Gel (Refresh Liquigel Ophthalmic)
1% (per mL): $0.69
Gel (Refresh Optive Ophthalmic)
1-0.9% (per mL): $1.20
Gel (TheraTears Nighttime Ophthalmic)
1% (per each): $0.52
Liquid (Sterile Lubricant Ophthalmic)
0.7% (per mL): $0.41
Solution (Biolle Tears Ophthalmic)
0.5% (per each): $0.30
Solution (Carboxymethylcellulose Sodium Ophthalmic)
0.5% (per mL): $0.40 - $0.73
Solution (Refresh Digital Ophthalmic)
0.5-1-0.5% (per mL): $1.24
Solution (Refresh Digital PF Ophthalmic)
0.5-1-0.5% (per each): $0.47
Solution (Refresh Optive Advanced Ophthalmic)
0.5-1-0.5% (per mL): $0.97
Solution (Refresh Optive Advanced PF Ophthalmic)
0.5-1-0.5% (per each): $0.48
Solution (Refresh Optive Mega-3 Ophthalmic)
0.5-1-0.5% (per each): $0.54
Solution (Refresh Optive Ophthalmic)
0.5-0.9% (per mL): $0.79
Solution (Refresh Optive PF Ophthalmic)
0.5-0.9% (per each): $0.41
Solution (Refresh Plus Ophthalmic)
0.5% (per each): $0.33
Solution (Refresh Relieva Ophthalmic)
0.5-0.9% (per mL): $1.31
Solution (Refresh Relieva PF Ophthalmic)
0.5-0.9% (per mL): $1.39
0.5-1% (per each): $0.54
Solution (Refresh Tears Ophthalmic)
0.5% (per mL): $0.49
Solution (TheraTears Extra Ophthalmic)
0.25% (per mL): $0.80
Solution (TheraTears Extra PF Ophthalmic)
0.25% (per each): $0.62
Solution (Theratears Ophthalmic)
0.25% (per mL): $0.93
Solution (Theratears PF Ophthalmic)
0.25% (per each): $0.52
Solution (Ultra Fresh Ophthalmic)
0.5% (per mL): $0.56
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Artificial tear substitute
Refresh Celluvisc may be confused with Restasis
None known.
There are no known significant interactions.
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