Over-the-Counter Eye Drops: Are Any of Them Safe to Use?
미국 식품의약국(FDA)은 안구 감염 위험 때문에 여러 주요 브랜드의 특정 안약을 구매하거나 사용하지 말 것을 소비자들에게 경고합니다.
인공눈물 제품은 세균 오염 위험으로 인한 감염 및 시력 손실 때문에 여러 차례 리콜되었습니다. 특히 2023년에서 2024년 사이에 에즈리케어(EzriCare), 델삼 파마(Delsam Pharma) 및 CVS, 월마트, 타겟 등의 자체 브랜드 제품이 대규모 리콜되었으며, 최근에는 시스테인(Systane)과 같은 특정 제품에서 곰팡이 문제가 발생하여 리콜되었습니다. 소비자들은 FDA 웹사이트에서 리콜 제품 목록을 확인하고, 리콜된 제품을 사용하지 않아야 하며, 충혈, 통증 또는 분비물이 있는 경우 의사와 상담해야 합니다. 또한, 방부제가 없는 일회용 바이알을 사용하는 것이 안전합니다.
미국 식품의약국(FDA)은 심각한 오염 위험(세균/곰팡이)으로 인해 감염, 시력 손실, 심지어 사망에까지 이를 수 있는 여러 일반의약품 안약(자체 브랜드 제품 포함)에 대해 광범위한 경고 및 리콜 조치를 발표했습니다. 2023년에는 Global Pharma 및 Kilitch Healthcare와 같은 제조업체에 대해 대규모 조치가 있었고, 최근에는 AvKARE에 대한 조치도 있었습니다. 따라서 iVIZIA 또는 다른 안약을 사용하는 경우, FDA의 경고 목록에서 특정 제품명이나 제조업체를 확인하십시오. 많은 브랜드가 이러한 광범위한 품질 문제의 영향을 받고 있습니다.
2023년부터 2024년까지 리더(Leader), 럭비(Rugby), 시스테인(Systane, Alcon), 에즈리케어(EzriCare), 델삼 파마(Delsam Pharma), 퓨어리 수딩(Purely Soothing) 및 CVS, 월마트, 타겟 등 자체 브랜드 제품을 포함한 여러 안약 제품들이 오염 위험(세균/곰팡이) 및 안전하지 않은 제조 과정으로 인해 리콜 조치되었습니다. 이러한 제품들은 심각한 감염이나 시력 손실을 유발할 수 있으며, 미국 식품의약국(FDA)은 여러 제품과 특정 제조 번호에 대해 경고를 발령했습니다. 최근에는 제조상의 문제로 인해 AvKARE 제품도 리콜 대상에 포함되었습니다.
- Global Pharma Healthcare/EzriCare/Delsam Pharma: Linked to severe infections and deaths, leading to recalls of EzriCare Artificial Tears and Delsam Pharma Ointment.
- Cardinal Health/Leader: Recalled various Leader brand lubricating drops due to potential contamination.
- Harvard Drug Group/Rugby: Recalled Rugby brand eye drops for similar reasons.
- Kilik Healthcare (India): Recalled store-brand drops sold at CVS, Walmart, Target (e.g., Up&Up, Equate) due to contamination.
- Alcon: Recalled one lot of Systane Lubricant Eye Drops Ultra PF (Lot 10101) for fungal contamination (Dec 2024).
- Purely Soothing: Recalled MSM drops for non-sterility.
- Stop Use Immediately: If you have any recalled products, stop using them.
- Check FDA Alerts: Refer to the FDA's website for detailed lists and specific lot numbers.
- Contact Doctor: Consult your doctor if you've used any recalled drops and experience eye pain, vision changes, or infection signs.
FDA sends warning letters to three eye drop manufacturers
At the beginning of July 2025, the FDA issued warning letters to executives from three manufacturers regarding violations pertaining to each of their respective over-the-counter (OTC) eye drop products.
These manufacturers:
- Théa Pharma, Inc. for its iVIZIA lubricant eye drops
- Covalent Medical (under Focus Vitamins) for its Revitalize Energizing Eye Drops
- Revitalize Energy, Inc. for its FOCUS PI Post-Injection Eye Drops
Where to start?
First up: iVIZIA. Available as part of Théa’s line of iVIZIA products, the iVIZIA eye drops are formulated with povidone 0.5% (the active ingredient) and several other inactive ingredients.
Its purpose:
- For temporary relief of:
- Burning and irritation due to eye dryness
- Discomfort due to minor irritations of the eye
- For use as a protectant and lubricant against further irritation or to relieve eye dryness
The drops are also reported to provide "instant and long-lasting relief of dry eye symptoms for up to 8 hours.”
And what are the issues the FDA has called out?
Per a July 9 warning letter sent to Théa’s President Susan K. Benton, the federal agency stated that a review of iVIZIA’s product labeling noted that the iVIZIA drops are:
- An unapproved new drug in violation of two sections of the Federal Food, Drug, and Cosmetic (FD&C) Act
- A misbranded product under one section of the FD&C Act
Start with those unapproved new drug violations.
Based on its review, the FDA referred to the iVIZIA drops as an “unapproved new drug introduced or delivered for introduction into interstate commerce” and in violation of the following FD&C Act sections:
- Section 505(a): Pertains to the approval of new drugs and details the submission process for market approval based on safety and effectiveness
- Section 301(d): Prohibits the introduction of misbranded or adulterated drugs into interstate commerce
Eye Drop Retailers and Product Information
| Retailer/Brand | Product | Product Information | National Drug Code (NDC) |
|---|---|---|---|
CVS Health | Lubricant Eye Drops 15 ml (single pack) | Carboxymethylcellulose Sodium 0.5% | 76168-702-15 |
| CVS Health | Lubricant Eye Drops 15 ml (twin pack) | Carboxymethylcellulose Sodium 0.5% | 76168-702-30 |
| CVS Health | Lubricant Gel Drops 15 ml (single pack) | Carboxymethylcellulose Sodium 1% | 76168-704-15 |
| CVS Health | Lubricant Gel Drops 15 ml (twin pack) | Carboxymethylcellulose Sodium 1% | 76168-704-30 |
| CVS Health | Multi-Action Relief Drops 15 ml | Polyvinyl Alcohol 0.5%, Povidone 0.6%, and Tetrahydrozoline Hydrochloride 0.05% | 76168-706-15 |
| CVS Health | Lubricant Gel drops 10 ml | Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3% | 76168-712-10 |
| CVS Health | Lubricant Eye Drops 10 ml (single pack) | Propylene Glycol 0.6% | 76168-714-10 |
| CVS Health | Lubricant Eye Drops 10 ml (twin pack) | Propylene Glycol 0.6% | 76168-714-20 |
| CVS Health | Mild Moderate Lubricating Eye Drops 15 ml (single pack) | Polyethylene Glycol 400 0.25% | 76168-711-15 |
Leader (Cardinal Health) | Eye Irritation Relief 0.5 FL OZ (15 ml) | Polyvinyl Alcohol 0.5%, Povidone 0.6% and Tetrahydrozoline Hydrochloride 0.05% | 70000-0087-1 |
| Leader (Cardinal Health) | Dry Eye Relief 0.5 FL OZ (15 ml) | Carboxymethylcellulose Sodium 1% | 70000-0089-1 |
| Leader (Cardinal Health) | Lubricant Eye Drops 0.5 FL OZ (15 ml) (single) | Carboxymethylcellulose Sodium 0.5% | 70000-0090-1 |
| Leader (Cardinal Health) | Lubricant Eye Drops 0.5 FL OZ (15 ml) (twin pack) | Carboxymethylcellulose Sodium 0.5% | 70000-0090-2 (carton) 70000-0090-1 (bottle) |
| Leader (Cardinal Health) | Dry Eye Relief 0.33 FL OZ (10 ml) | Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3% | 70000-0088-1 |
| Leader (Cardinal Health) | Lubricant Eye Drops 0.33 FL OZ (10 ml) | Polyethylene Glycol 0.6% | 70000-0587-1 |
Rugby (Harvard Drug Group) | Lubricating Eye Drops 0.5 oz (15 ml) | Polyvinyl Alcohol 1.4% | 0536-1325-94 |
| Rugby (Harvard Drug Group) | Lubricating Tears Eye Drops 0.5 oz (15 ml) | Dextran/Hypromellose 0.1%/0.3% | 0536-1282-94 |
Rite Aid | Lubricant Eye Drops 15 ml (twin pack) | Carboxymethylcellulose Sodium 0.5% | 11822-4811-5 |
| Rite Aid | Lubricant Eye Drops 10 ml (twin pack) | Propylene Glycol 0.6% | 11822-4811-3 |
| Rite Aid | Gentle Lubricant Gel Eye Drops 15 ml | Hypromellose 0.3%, Glycerin 0.2%, Dextran 70 0.1% | Not provided by the manufacturer |
| Rite Aid | Lubricant Gel Drops 15 ml | Carboxymethylcellulose Sodium 1% | 11822-4540-5 |
| Rite Aid | Lubricating Gel Drops 10 ml | Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3% | 11822-4540-3 |
| Rite Aid | Multi-Action Relief Drops 15 ml | Polyvinyl Alcohol 0.5%, Povidone 0.6% and Tetrahydrozoline Hydrochloride 0.05% | 11822-2254-3 |
| Target | Up&Up Dry Eye Relief 15 ml (twin pack) | Carboxymethylcellulose Sodium 0.5% | 76168-800-30 |
| Target | Up&Up High Performance Lubricant Eye Drops 15 ml (single pack) | Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3% | 11673-522-15 |
| Target | Up&Up High Performance Lubricant Eye Drops 15 ml (twin pack) | Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3% | 11673-522-30 |
Velocity Pharma LLC | Lubricant Eye Drop 10 ml (triple pack) | Propylene Glycol 0.6% | 76168-502-30 |
Walmart | Equate Hydration PF Lubricant Eye Drop 10 mL | Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3% | 79903-168-01 |
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