Health

Uncovering the Truth: The Complete Timeline of the FDA/CDC Eye Drop Recall

The outbreak of eye infections linked to contaminated eye drops in the United States has caused significant concern and action from health authorities. This detailed timeline follows the unfolding events that led to the involvement of the FDA and CDC and the subsequent recalls of various eye drop products. From the initial identification of the dangerous Pseudomonas aeruginosa bacterium to the rigorous investigations and the false media accusations, this article provides a comprehensive account of how the crisis was managed and the critical findings that cleared Global Pharma Healthcare of any wrongdoing.

January 2023: Concerns Raised by CDC

In January 2023, the CDC identified a potential link between eye drops and an uptick in eye infections. The culprit was Pseudomonas aeruginosa, a bacterium notorious for its antibiotic resistance and severe health impacts, particularly in healthcare settings.

January 31, 2023: CDC Investigation Begins

On January 31, 2023, the CDC began investigating a cluster of Pseudomonas aeruginosa infections across multiple states. The investigation aimed to determine whether eye drop products were responsible for the outbreak.

February 2023: Long-Term Care Center Focus

A significant part of the investigation occurred at a long-term care center in Connecticut, where two dozen cases were identified. Investigators suspected eye drops as the infection source, but the center’s records were insufficient to confirm the specific product used.

February 2023: Voluntary Recalls

Acting proactively, several manufacturers voluntarily recalled their products without concrete evidence of contamination:

1. February 2, 2023:
   • EzriCare Artificial Tears Lubricant Eye Drops (Global Pharma Healthcare Private LTD.)
   • Delsam Pharma Artificial Tears
2. February 24, 2023:
   • Delsam Pharma Artificial Eye Ointment

March 2023: Mandatory Recalls

With ongoing investigations, the FDA issued mandatory recalls for several eye drop brands:

• March 1, 2023:
  • Apotex Brimonidine Tartrate Ophthalmic Solution
• March 3, 2023:
  • Pharmedica Purely Soothing MSM Drops
• March 20, 2023:
  • Teva Pharmaceuticals Clear Eyes Once Daily Eye Allergy Itch Relief

Formal Warnings Issued by FDA

The FDA also sent formal warning letters to additional brands, urging voluntary recalls:

• CVS Health Lubricant Eye Drops
• CVS Health Multi-Action Relief Drops
• Rugby Lubricating Tears Eye Drops
• Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops
• Leader Dry Eye Relief
• Rite Aid Gentle Lubricant Gel Eye Drops
• Target Up&Up Extreme Relief Dry Eye
• Velocity Pharma LLC Lubricant Eye Drop
• Walmart Equate Hydration PF Lubricant Eye Drops

August 30, 2023: Comprehensive Recall

By summer 2023, after thorough testing, the FDA ordered a recall of 28 brands that had not voluntarily recalled their products:

• Multiple CVS Health Lubricant and Gel Drops products
• Leader Eye Irritation Relief and Dry Eye Relief
• Rugby Lubricating Eye Drops
• Rite Aid Lubricant and Gel Drops
• Target Up&Up Dry Eye Relief and High Performance Lubricant Eye Drops
• Velocity Pharma LLC Lubricant Eye Drop
• Walmart Equate Hydration PF Lubricant Eye Drop

February 3, 2024: FDA Issues Additional Eye Drop Warnings

On February 3, 2024, the Food and Drug Administration (FDA) issued a critical warning to consumers, advising against the purchase or use of the following eye drop brands due to a substantial risk of eye infection:

• South Moon
• Rebright
• FivFivGo

Testing and Findings

The outbreak strain, identified as sequence type (ST) 1203, carried resistance genes blaVIM-80 and blaGES-9, which provide resistance to carbapenems. The CDC’s genome data indicated that this strain had not been previously identified. However, FDA tests on unopened bottles of EzriCare Artificial Tears found no trace of the outbreak strain.

Findings Clear Global Pharma Healthcare

In February, joint investigations by India’s top drug regulator and state drug controller confirmed that Global Pharma Healthcare adhered to rigorous quality control measures. Control samples from the manufacturing plant near Chennai, India, and additional samples tested in Bengaluru showed no contamination. The VIM-GES-CRPA outbreak cluster was found to be at least 32 SNPs distant from the Indian contextual isolates used by Global Pharma, making it scientifically impossible for the contamination to have originated from their facilities.

These findings exonerated Global Pharma Healthcare, disproving earlier media accusations and legal claims that suggested their products were responsible for the outbreak. The rigorous testing and quality control measures in place at Global Pharma’s facilities were validated, clearing them of any wrongdoing.

False Accusations and Media Reactions

Despite lacking evidence, media outlets prematurely implicated Global Pharma, leading to class action lawsuits and negative publicity. These allegations were later disproved, demonstrating that the contamination could not have originated from Global Pharma’s facilities.

Uncovering the Truth

Through scientific evidence the contaminant that has caused the issues experienced by a number of users of eye drops in the United States, is a rare and extensively drug-resistant Pseudomonas aeruginosa (CRPA), carrying both VIM-80 and GES-9 . It belongs to sequence type (ST) 1203 and contains resistance genes blaVIM-80 and blaGES-9.

Through testing and findings it was proved that the VIM-GES-CRP, an outbreak cluster was at least 32 SNPs distant from Indian contextual isolates used by Global Pharma in the production of the EzriCare & Delsam products. As such it is scientifically impossible that this contamination could have originated in the EzriCare & Delsam Pharma’s products from the manufacturing unit.

It’s also important to note that voluntary recalls are proactive measures taken by companies to ensure safety and quality. They do not necessarily indicate a product defect or fault but reflect the company’s diligence in addressing potential issues. By initiating a voluntary recall, companies demonstrate their commitment to consumer safety, and maintaining trust and confidence in their products.