April 28, 2021
Sterility concerns due to defective containers have prompted Edge Pharma to voluntarily recall 5850 syringes of Betadine (povidone iodine) ophthalmic solution. The April 28, 2021, US Food and Drug Administration (FDA) Enforcement Report advised that “syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility.”
The recall affects Betadine (povidone-iodine) 5%, 0.5 mL per syringe, from lot 02-2021-16@4 (beyond use date 5/31/2021). The product was distributed throughout the United States.
Edge Pharma initiated the recall April 12, 2021. On April 19, 2021, the FDA designated the recall Class II. Products affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.
Betadine ophthalmic solution is a prescription microbicide used to prevent infection during surgery and other procedures involving the eyes.