Update [2/22/2023] FDA recommended that Global Pharma recall Delsam Pharma’s Artificial Eye Ointment, and the firm agreed to initiate a recall.
Update [2/21/2023] In addition to Artificial Tears products, FDA is also now warning consumers and Health care professionals not to purchase or use Delsam Pharma’s Artificial Eye Ointment due to potential bacterial contamination. This is an over-the-counter product, manufactured by Global Pharma Healthcare Private Limited, intended to be sterile.
En Español
These are over-the-counter products, manufactured by Global Pharma Healthcare Private Limited, intended to be sterile.
Global Pharma initiated a voluntary recall at the consumer level of all unexpired lots of EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears. FDA recommended this recall due to the company’s current good manufacturing practice (CGMP) violations, including lack of appropriate microbial testing, formulation issues (the company manufactures and distributes ophthalmic drugs in multi-use bottles, without an adequate preservative), and lack of proper controls concerning tamper-evident packaging.
FDA is collaborating with the Centers for Disease Control and Prevention (CDC) and state and local Health departments to investigate a multistate outbreak involving a rare, extensively drug-resistant strain of Pseudomonas aeruginosa bacteria. As of January 31, 2023, CDC identified 55 patients in 12 states with infections that have been linked by epidemiologic and laboratory evidence to use of EzriCare Artificial Tears. Associated adverse events include hospitalization, one death with bloodstream infection, and permanent vision loss from eye infections. CDC issued an alert recommending consumers stop using EzriCare Artificial Tears pending additional guidance from CDC and FDA.
FDA also placed Global Pharma Healthcare Private Limited on import alert for providing an inadequate response to a records request and for not complying with CGMP requirements. The import alert prevents these products from entering the United States. FDA encourages Health care professionals and patients to report adverse events or quality problems with any medicine to FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online at Medwatch; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
Consumers may also report adverse reactions by contacting FDA’s Consumer Complaint Coordinators.
