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US/Silver Spring: Global Pharma Healthcare, a Chennai, Tamilnadu, India establishment, recalls all current batch/lots of EzriCare and Delsam Pharma branded Artificial Tears Lubricant Eye Drops from the American marketplace due to suspected Verona Integron-mediated Metallo-β-lactamase (VIM)- and Guiana-Extended Spectrum-β-Lactamase (GES)-producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA) contamination with consequential risks of eye infections, permanent loss of vision and bloodstream infection, all serious health and safety hazards requiring immediate medical intervention to minimize pain and suffering as well as prevent life-altering injury or death.
Additional information:
The US Food and Drug Administration (“FDA”) reports the following Drug are subject to this recall:
- Ezricare Artificial Tears Lubricant Eye Drops with an active ingredient of Carboxymethylcellulose Sodium, sold in 10 mg in 1 mL, 1/2 fluid ounce (15 ml) bottles with an NDC of 79503-0101-15 and a UPC of 3 79503 10115 7
- Delsam Pharma Artificial Tears Lubricant Eye Drops with an active ingredient of Carboxymethylcellulose Sodium, sold in 10 mg in 1 mL, 1/2 fluid ounce (15 ml) bottles with an NDC of 72570-121-15 and a UPC [MISSING]-72570-0121-15.
Please consult the photograph above for details of the drug’s packaging, design and retail presentation. One (1) additional image of the recalled Artificial Tears Lubricant Eye Drops 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.
These EzriCare and Delsam Pharma branded Artificial Tears Lubricant Eye Drops were known to be marketed, distributed and sold in all US states, although it is always possible these drug products had wider distribution within the country. When in doubt, please contact the manufacturer for specific product information.
If you are concerned about distribution outside the United States, please contact the manufacturer for specific product information.
According to the FDA, Global Pharma Healthcare has recalled all current batch/lots of EzriCare and Delsam Pharma branded Artificial Tears Lubricant Eye Drops from the American marketplace due to suspected Verona Integron-mediated Metallo-β-lactamase (VIM)- and Guiana-Extended Spectrum-β-Lactamase (GES)-producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA) infections. As a result of this reported defect, you should neither serve nor consume the recalled Eye Drops identified above.
Please note: this expands and formally recalls EzriCare Artificial Tears that was published on Recalls Direct on or about February 3, 2023. You can read this earlier warning here: https://wp.me/p2bVty-n7b.
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.
==> Never depend on your senses of sight, smell, taste or touch to confirm drug poisoning, adulteration or contamination. If in doubt about the safety of any food or drug, return it to your retailer for refund and safe disposal, making sure neither small children nor household pets can access the suspect drug products.
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 following:
For products sold under the Ezricare brand, please contact Aru Pharma/Ezricare, LLC at +1-518-738-7602 from 11:00 AM to 4:00 PM Monday to Friday or by e-mail at arupharmainc@yahoo.com.
For products sold under the Delsam Pharma brand, please contact Delsam Pharma LLC toll-free at 1-866-826-1309 from 11:00 AM to 4:00 PM Monday to Friday or by e-mail at delsampharma@yahoo.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 Global Pharma Healthcare, please search for “Global Pharma” using the Search Box at the top of this page.
==> To see other recalls and notifications for products manufactured, marketed and/or sold by Delsam Pharma LLC, please search for “Delsam” 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: 16768-2023
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Filed under: Bacterial or viral contamination, Food & Drink, 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: 16768-2023, respiratory infection, Sepsis, suspected bacterial contamination, Urinary Tract Infection, US FDA, US Food and Drug Administration, vision loss |
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