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US/Atlanta: The US Centers for Disease Control and Prevention (“CDC”), an Atlanta, Georgia based health promotion and disease prevention authority, issues a Health Advisory against the use of certain batch/lots of EzriCare Artificial Tears due to suspected multi-state infections with an extensively drug-resistant strain of Verona Integron-mediated Metallo-β-lactamase (“VIM”) and Guiana-Extended Spectrum-β-Lactamase (“GES”)-producing Carbapenem-resistant Pseudomonas Aeruginosa (VIM-GES-CRPA) and consequential risks of bacterial infection, severe illness and/or possible life-changing complications including visual impairment and/or blindness, all serious and potential fatal hazards, requiring immediate medical intervention to minimize pain and suffering as well as prevent life-altering injury or death.
Additional information:
The US Centers for Disease Control and Prevention (“CDC”) reports the following Drugs are subject to this Health Advisory:
- EzriCare Artificial Tears Lubricant Eye Drops, with an active ingredient of Carboxymethylcellulose Sodium, 10 mg in 1 mL, sold in 1/2 fluid ounces (15 mL) containers with an NDC of 79503-0101-15. The product was reportedly formulated, designed and imported by Aru Pharma Inc in the US and were manufactured by Global Pharma Healthcare PVT LTD in India.
Please consult the photograph above for details of the food’s packaging, design and retail presentation. One (1) additional image of the recalled EzriCare Artificial Tears can be found on the Web site above.
==> No item numbers, best-before date codes, manufacturing date codes, production dates, expiry dates, regulatory approval designations, registration numbers, agency approval designations or other identification numbers were listed with this recall notification.
The Centers for Disease Control and Prevention (CDC) has issued a Health Alert Network (“HAN”) Health Advisory concerning infections with an extensively drug-resistant strain of Verona Integron-mediated Metallo-β-lactamase (“VIM”) and Guiana-Extended Spectrum-β-Lactamase (“GES”)-producing Carbapenem-resistant Pseudomonas Aeruginosa (VIM-GES-CRPA) in twelve (12) states. Most affected patients reported using artificial tears. Patients reported more than ten (10) different brands of artificial tears, and some patients used multiple brands.
The majority of affected patients who used artificial tears reported using EzriCare Artificial Tears, a preservative-free, over-the-counter product packaged in multi-dose bottles. CDC laboratory testing identified the presence of the outbreak strain in opened EzriCare bottles with different lot numbers collected from two states.
As of January 31, 2023, CDC in partnership with state and local health departments, identified fifty-five (55) case-patients in twelve (12) states (CA, CO, CT, FL, NJ, NM, NY, NV, TX, UT, WA and WI) with VIM-GES-CRPA, a rare strain of extensively drug-resistant Pseudomonas Aeruginosa. Thirty-five (35) patients are linked to four (4) healthcare facility clusters. Dates of specimen collection were from May 2022 to January 2023. Patients had a variety of conditions including Keratitis, Endophthalmitis, Respiratory Infection, Urinary Tract Infection, and Sepsis. Patient outcomes include permanent vision loss resulting from cornea infection, hospitalization and one (1) death due to systemic infection.
Testing of unopened bottles of EzriCare Artificial Tears is ongoing to assist in evaluating for whether contamination may have occurred during manufacturing.
Proposed Remedy for Consumers:
==> Patients and healthcare providers should immediately discontinue using EzriCare Artificial Tears pending additional guidance from CDC and the Food and Drug Administration (“FDA”).
In addition, the CDC recommends the following:
- If you were told to use EzriCare Artificial Tears by your physician or other healthcare provider, you should immediately follow up with your healthcare provider for an alternative artificial tears product to use.
- If you used EzriCare Artificial Tears and have signs and/or symptoms of an eye infection, such as discharge from the eye, eye pain or discomfort, redness of the eye or eyelid, feeling of something in the eye, increased sensitivity to light, or blurry vision, should seek timely medical care. At this time, CDC does not recommend testing of patients who have used this product and who are not experiencing any signs or symptoms of infection.
Proposed Remedy for Healthcare Providers:
- Immediately discontinue using EzriCare Artificial Tears in your practice pending additional guidance from CDC and FDA.
- Advise patients who used EzriCare Artificial Tears to monitor for signs and symptoms of infection. Perform culture and antimicrobial susceptibility testing when clinically indicated.
- Healthcare providers treating patients for Keratitis or Endophthalmitis should ask patients if they have used EzriCare Artificial Tears. Providers should consider performing culture and antimicrobial susceptibility testing to help guide therapy if patients report use of this product.
- Healthcare providers treating VIM-GES-CRPA infections should consult with a specialist knowledgeable in the treatment of antibiotic-resistant bacteria to determine the best treatment option. VIM-GES-CRPA isolates associated with this outbreak are extensively drug-resistant. Isolates that underwent susceptibility testing at public health laboratories were not susceptible to Cefepime, Ceftazidime, Piperacillin-Tazobactam, Aztreonam, Carbapenems, Ceftazidime-Avibactam, Ceftolozane-Tazobactam, Fluoroquinolones, Polymyxins, Amikacin, Gentamicin and Tobramycin. A subset of three (3) isolates that underwent antimicrobial susceptibility testing for Cefiderocol at clinical laboratories or CDC were susceptible to this agent.
- Place patients infected or colonized with VIM-GES-CRPA and admitted to acute care settings in isolation and use Contact Precautions. For residents of skilled nursing facilities who are infected or colonized with VIM-GES-CRPA, use Enhanced Barrier Precautions if the resident does not have an indication for Contact Precautions.
- At this time, CDC does not recommend testing patients who have used this product and who are not experiencing any signs or symptoms of infection.
==> Never depend on your senses of sight, smell, taste or touch to confirm drug and/or food poisoning, adulteration or contamination. If in doubt about the safety of any drug or medication, return it to your retailer, pharmacist or healthcare provider.
Disposal of this product must be in accordance with local municipal hazardous waste requirements to protect the drinking water supply and the ecosystem. Do not dispose of this product through your household sewer system. Instead, consult with your local pharmacist or municipal waste authority for disposal instructions.
==> If you have a medical emergency, please contact 9-1-1, your closest hospital or emergency center equipped to properly treat Keratitis, Endophthalmitis, Respiratory Infection, Urinary Tract Infection, Sepsis and/or vision loss from cornea infection.
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If you have any further questions, comments or complaints about this recall, please contact the company by e-mail at at@ezricare-info.com.
==> To see other recalls and notifications caused by contaminated, adulterated or mislabeled Artificial Tears, please search for “eye drops” or more generically, “drugs” using the Search Box at the top of this page.
==> To see other recalls and notifications caused by suspected generic Bacterial contamination, please search for “bacterial” using the Search Box at the top of this page.
==> To see other recalls and notifications caused by suspected Pseudomonas Aeruginosa contamination, please search for “Pseudomonas” using the Search Box at the top of this page.
==> To see other recalls and notifications for products manufactured, marketed and/or sold by EzriCare, please search for “EzriCare” using the Search Box at the top of this page.
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More information about this recall:
CDC Alert: CDCHAN-00485
Recalls Direct RIN: 16748-2023
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Filed under: Bacterial or viral contamination, Dietary Supplements, Food & Drink, Probiotics, Pseudomonas aeruginosa [Gram-neg], US CDC, US FDA | Tagged: bacterial contamination hazard, Carbapenem-resistant Pseudomonas Aeruginosa, CDC, CDC Alert: CDCHAN-00485, Centers for Disease Control and Prevention, Cornea Infection, drug, Endophthalmitis, eye drops, FDA, Health Advisory, Keratitis, Pseudomonas aeruginosa, Pseudomonas aeruginosa contamination hazard, Recalls Direct RIN: 16748-2023, respiratory infection, Sepsis, suspected bacterial contamination, Urinary Tract Infection, US FDA, US Food and Drug Administration, vision loss |
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