Tag

Global Pharma Healthcare

All articles tagged with #global pharma healthcare

health2 years ago

Contaminated eye drops cause fourth death, CDC reports.

A fourth person has died from an outbreak of an extensively drug-resistant bacteria linked to Global Pharma Healthcare's recalled eye drops. As of May 15, 81 patients across 18 states have become infected with Pseudomonas aeruginos, with 14 reporting vision loss, four having their eyeballs removed, and four others dying. The CDC has been investigating the outbreak, which has been tied to artificial tears manufactured by Global Pharma Healthcare earlier this year, alongside the FDA and other state and local health officials. The company did not follow proper sterilization or cleaning procedures at its manufacturing facility, according to the FDA.

health2 years ago

CDC Reports 4 Deaths and 81 Cases in Contaminated Eye Drops Outbreak.

A fourth person has died from an outbreak of Pseudomonas aeruginosa, an extensively drug-resistant bacteria linked to Global Pharma Healthcare's recalled eyedrops. As of May 15, 81 patients across 18 states have become infected, with 14 reporting vision loss, four having their eyeballs removed, and four others dying. The CDC has been investigating the outbreak, which has been tied to artificial tears manufactured by Global Pharma Healthcare earlier this year, and has issued a recall for all lots within the expiry of the EzriCare and Delsam Pharma’s artificial tears products due to possible contamination.

health2 years ago

FDA Finds Sterility Issues at Eyedrops Manufacturer Linked to Deaths and Outbreaks

The FDA has released a preliminary inspection report stating that the manufacturer of eyedrops, Global Pharma Healthcare, lacked measures to ensure sterility at its factory in India. The plant produced eyedrops that have been linked to 68 bacterial infections in the US, including three deaths and eight cases of vision loss. The FDA inspectors found about a dozen problems with how the company made and tested its eyedrops, including a deficient manufacturing process that was used between December 2020 and April 2022. The FDA is responsible for assuring the safety of foreign products shipped to the US, but it has long struggled to keep pace with international pharmaceutical supply chains that increasingly begin in India and China.

health2 years ago

FDA finds sterilization issues at maker of eye drops linked to deadly outbreak.

An FDA inspection found that Global Pharma Healthcare, the manufacturer of EzriCare Artificial Tears eye drops linked to an outbreak of serious bacterial infections in the US, did not follow proper protocol to prevent contamination of its products. The inspection resulted in 11 observations, including a "manufacturing process that lacked assurance of product sterility." The FDA continues to monitor the issue and is working with the CDC and the companies recalling affected products. Consumers are urged to stop using these products which may be harmful to their health.