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Medical vials manufacturing

Eyedrop Warnings Illustrate Importance of Process Controls

Eyedrops are essential for many people with dry eyes or other conditions, but a recent FDA Warning has shown nearly 30 over-the-counter eye drop products to be dangerous for consumers with FDA issuing a warning to not purchase and immediately stop using the listed products. With FDA adding an additional product on October 30 to the initial list (published on October 27),  it is recommended that anyone using any eyedrops check out and watch the FDA page for current and any additional brands or information.

The most recent list includes products branded by CVS, Rite Aid, Target and Walmart, who are pulling the products from their shelves, along with products from Cardinal Health (Rugby and Leader) and Velocity Pharma that may still be available but should not be used.

Although the manufacturer of the products has not yet been disclosed by FDA, the agency has recommended that all lots be recalled. This followed an FDA investigator finding of “insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility.”

With this latest warning following an outbreak earlier this year  in which a drug-resistant bacteria that is able to spread person-to-person was linked to the products and caused blindness and deaths, the issues illustrate the critical importance of process controls in any manufacturing facility – including that of foods and dietary supplements. Insanitary conditions can result in any number of contamination issues, making environmental monitoring and control essential in the manufacture of safe foods and drugs.

COVID Risk Matrix:


Infectious Disease News:

  • A newly published article in the Canadian Medical Association Journal suggests that more than 4 out of 10 elderly individuals may have avoided Covid infection so far – while they still remain at the highest risk for hospitalization and death. Experts have continued to encourage elderly adults to obtain a Covid vaccine.
  • An article published by New York Times which summarizes an FDA study suggests that Covid shots may slightly raise stroke risk in oldest recipients when administered along with a high-dose flu vaccine. The risk associated is in individuals 65 years of age and older and the outcome was noted to be clearest in adults 85 and older. There are three cases for every 100,000 doses given. A separate analysis by the agency points towards an increased risk of seizures after Covid vaccinations in children ages 2 to 5.
  • Pfizer and BioNTech announce that the formulations of a combination vaccine evaluated in their Phase 1/2 study demonstrated robust immune responses to influenza A, influenza B, and SARSCoV-2 strains. The safety profile of the mRNA-based combination vaccine candidates consistent with the companies’ COVID-19 vaccine. A Phase 3 trial will start in the coming months.
  • This year, the spread of measles disease is observed in the European region, as well as in neighboring countries – Turkey, the Russian Federation, Iran, Kazakhstan and Georgia. In this regard, over the past year, rare cases of measles infection have been observed in Azerbaijan from people arriving from other countries, mainly among unvaccinated children.  
  • WHO has warned of an imminent public health catastrophe in Gaza amid overcrowding, mass displacement and damage to infrastructure. A spokesperson from the UN Children’s Fund warned of the risk of infant deaths due to dehydration, with water output at 5% of normal levels. Many individuals are suffering from trauma and severe stress.

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