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Ophthalmic Injection Recalled


January 28, 2021

Edge Pharma is recalling 48 syringes of ceftazidime ophthalmic solution because of a lack of assurance of sterility, according to the January 27, 2021, US Food and Drug Administration (FDA) Enforcement Report. 

The recall affects ceftazidime sterile ophthalmic solution for intraocular injection, 11.25 mg/0.5 ml (22.5 mg/ml), 0.5 ml per syringe, from lot 02-2020-04@4. The product was distributed throughout the United States. 

Edge Pharma voluntarily initiated the recall March 19, 2020. The FDA designated the recall Class II on January 19, 2021. Use of a product under a Class II recall could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm. 

Ceftazidime ophthalmic injection is used to treat endophthalmitis, an infection of the tissues or fluid inside the eye.

Jolynn Tumolo

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