Allergan, PLC. recalls OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic applicator contained within carton, Rx only,…

Recall date

December 20, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0387-2019

FDA classification

Class II

Brand / firm

Allergan, PLC.

Sold / distributed

Product was distributed to various accounts throughout the United States including VA and Government Accounts

Why it was recalled

GMP Deviations: A silicone particulate was noted in Ozurdex.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic applicator contained within carton, Rx only, Allergan Inc Irvine, CA 92612, NDC 0023-3348-07