The FDA has issued a new recommendation for Global Pharma Healthcare Private Limited (Global Pharma) to recall Delsam Pharma’s Artificial Eye Ointment due to potential bacterial contamination.
I need some background.
This latest recall recommendation follows the Centers for Disease Control and Protection (CDC) issuing a health alert earlier this month for the use of EzriCare Artificial Tears (carboxymethylcellulose sodium 10 mg) as well as Delsam Pharma’s Artificial Tears after 55 patient cases of infection were reported across 12 states. That number has since risen to 58 patients in 13 states.
Both products are manufactured by Global Pharma.
What were the infections?
Infections consisted of Verona Integron‐mediated Metallo‐β‐lactamase (VIM)‐ and Guiana‐Extended Spectrum‐β‐Lactamase (GES)‐ producing carbapenem‐resistant Pseudomonas aeruginosa (VIM‐GES‐CRPA).
See here for more details, including patient symptoms.
Over 10 different artificial tears brands were included in the recall, with the majority of cases involving EzriCare’s preservative-free product.
So this is a new recall?
Yes. While the FDA’s initial recommendations were to stop use of EzriCare and Delsam Pharma’s artificial tears products, this is a new warning for Global Pharma’s over-the-counter ointment.
What brought it on?
The FDA implemented the recall as a result of Global Pharma’s violations to the current good manufacturing practice (CGMP), which included a lack of appropriate microbial testing, formulation issues, and a lack of proper controls with tamper-evident packaging.
Is Global Pharma cooperating?
According to the FDA, the company agreed to initiate a recall.