FDA 通报在佛罗里达和佐治亚州发现仿冒非处方眼药水，两款产品检出细菌污染
Counterfeit Versions of Eye Drops Found in Several States
FDA 通报在佛罗里达和佐治亚州面向西班牙语顾客的商店中发现仿冒非处方眼药水，产品也可能出现在路易斯安那、密西西比、北卡罗来纳等州。
材料逐项列出正品与仿冒眼药水在批号、有效期和标签语言上的差别，便于对照识别货架上的产品。
Counterfeit versions of over-the-counter eye drops have been found in Florida and Georgia in stores serving primarily Spanish-speaking customers. These products also may be in Louisiana, Mississippi, North Carolina and potentially other states.
Do not use counterfeit eye drops as the quality is unknown and several of these products have tested positive for bacterial contamination. Using counterfeit eye drops can pose a serious risk to eye health and may cause injury, infection or vision problems.
The FDA takes reports of counterfeit products seriously. The FDA is not aware of adverse events associated with any of these counterfeit products. The FDA’s investigation and product testing are ongoing. The agency is currently working with the distributors to identify, investigate and remove unlawful eye drops found in the U.S. drug supply.
How to identify the counterfeit products
| Authentic product | Counterfeit product |
Product: Colirio Ocusan Fast Redness Relief Company on the label is DLC Laboratories Inc. Carton is labeled with an expiration date of 9/2027 or earlier Carton is labeled with NDC 24286-1575-1 Bottle has a white cap Carton and bottle contain information in English only Carton contains a Drug Facts panel Bottom of the carton contains a barcode and ‘Made in Korea’ | Product: Colirio Ocusan Alivio rapido del enrojecimiento Company on the label is DLC Laboratories Inc. Carton is labeled with an expiration date of 12/2030 Carton is labeled with lot number 5542D12 Bottle has a red cap Carton and bottle contain information in Spanish only Carton does not include a Drug Facts panel Bottom of the carton does not contain any information |
Product: Ocusan Dry Eyes Company on the label is DLC Laboratories Inc. Carton is labeled with an expiration date of 9/2027 or earlier Carton is labeled with NDC 24286-1292-5 Bottle has a white cap Carton and bottle contain only English language information Carton contains a Drug Facts panel The bottom of the carton contains a barcode and ‘Made in Korea’ | Product: Ocusan Ojos Secos Company on the label is DLC Laboratories Inc. Carton is labeled with an expiration date of 12/2030 Carton is labeled with lot number 5542D12 Bottle has a blue cap Carton and bottle contain only Spanish language information Carton does not include a Drug Facts panel Bottom of the carton does not contain any information |
Product name: Colirio Manzanill A+ Redness Reliever & Lubricant Company on the label is ProMex LLC; the side panel of the carton states the product is ‘Distributed By PRO-MEX' Carton is labeled with an expiration date of 11/2027 The front of the carton contains the word ‘STERILE’ on the bottom left, and the word ‘Alivia’ is in yellow font Back and side panels of the carton contain Drug Facts panels Bottom of the carton contains lot number and expiration date | Product name Colirio Manzanilla Company on the label is ProMex LLC Carton is labeled with an expiration date of 12/2030 The front of the carton does not contain the word ‘STERILE’ on the bottom left, and the word ‘Alivia’ is in red font Carton does not include a Drug Facts panel Bottom of the carton does not contain any information |
Product name: Manzanilla Sophia Usala Diario Company on the label is Laboratorios Sophia Carton side panel contains bold heading that reads ‘INSTRUCTIVO’ and contains images of opening the bottle, instilling the eye drop and closing the bottle The other side panel of the carton contains a green bar on the top with white text that reads ‘FÓRMULA’ | Product name: Manzanilla Sophia Usala Diario Company on the label is Laboratorios Sophia Carton is labeled with an expiration date of 12/2030 Carton contains lot number 160701DHR0 Carton side panel that states ‘Precio Maximo Al Publico $33.00’ over a red burst Carton side panel and product bottle that states ‘Dina distribuidor naturista’ |
| There is no authentic version of Manzanilla Sophia Ojo Rojo | Product name: Manzanilla Sophia Ojo Rojo Company on the label is Laboratorios Sophia Carton contains an expiration date 10/2030 Carton is red and contains an image of a red eye |
Counterfeit eye drops with confirmed contamination
DLC Laboratory tested two counterfeit products and found bacterial contamination:
- Colirio Ocusan Alivio rapido del enrojecimiento is contaminated with Staphylococcus bacteria
- Ocusan Ojos Secos is contaminated with an unconfirmed type of bacteria
This bacterial contamination may cause serious eye infections that could result in partial vision loss or blindness. Patients experiencing signs or symptoms of an eye infection after using any of these products should contact a healthcare professional or seek medical care immediately.
Information for consumers
- Immediately stop using these products.
- Contact your doctor if you have used any of these products and have concerns or signs of an eye infection, including eye redness, eye discharge and eye pain or discomfort.
- If you see these products on store shelves, do not purchase them and notify the store.
- Report adverse events through FDA’s MedWatch reporting program either online or by phone: 1-800-FDA-1088 (1-800-332-1088).
- One lot of Colirio Manzanill A+ Redness Reliever & Lubricant was recalled at the retail level on Sept. 11, 2026, by K.C. Pharmaceuticals. The recalled product is labeled with a lot number AR25N01 and expiration date of 11/2027. While PRO-MEX is listed as the product distributor, which is the same as the product in the table, this recall is a separate issue from the counterfeit issue.
Information for health care professionals
- If a patient has an eye infection, inquire about all ophthalmic products they use.
- Report adverse events through FDA’s MedWatch reporting program.
Information for retailers
- Contact the company name on the product label if you suspect you have counterfeit products on your shelves.
Product images of authentic vs. counterfeit products
Colorio Ocusan Fast Redness Relief
Authentic | Counterfeit |
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Ocusan Dry Eyes
Authentic | Counterfeit |
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Manzanill A+ Redness Reliever & Lubricant Eye Drops
Authentic | Counterfeit |
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Manzanilla Sophia Usala Diario
Authentic | Counterfeit |
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Manzanilla Sophia Ojos Rojos
Authentic | Counterfeit |
| This product does not have an authentic version. |
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来源：FDA 官方药品与生物制品信息 · fda.gov