Allergan plc is recalling 133,716 Ozurdex (dexamethasone) intravitreal implants, 0.7 mg (NDC 0023-3348-07), because of the discovery of a silicone particulate. The recall was included in the January 16, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects Ozurdex from more than 20 lots: E78689 (Exp. 6/21/19), E78726 (Exp. 6/29/19), E78729 (Exp. 7/1/19), E78894 (Exp. 8/9/19), E79157 (Exp. 9/5/19), E79233 (Exp. 9/15/19), E79366 (Exp. 10/6/19), E79891 (Exp. 12/7/19), E80122 (Exp. 1/18/20), E80216 (Exp. 2/6/20), E81080 (Exp. 5/9/20), E81083 (Exp. 5/22/20), E81273 (Exp. 5/31/20), E81344 (Exp. 6/21/20), E82526 (Exp. 12/11/20), E82638 (Exp. 12/20/20), E82738 (Exp. 1/18/21), E82741 (Exp. 1/23/21), E82847 (Exp. 1/29/21), E82852 (Exp. 2/1/21), E83029 (Exp. 2/26/21), and E83364 (Exp. 4/18/21).
The recalled Ozurdex was distributed throughout the United States, including the Department of Veterans Affairs and other government accounts.
Allergan plc initiated the recall December 20, 2018. The FDA designated it Class II, communicating use of the product may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.
Ozurdex is a prescription corticosteroid medication implant injected into the eye to treat adults with diabetic macular edema, swelling of the macula following branch retinal vein occlusion or retinal vein occlusion, or noninfectious inflammation of the uvea affecting the back segment of the eye.
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