FDA recall D-0387-2019

Product

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

Reason for recall

GMP Deviations: A silicone particulate was noted in Ozurdex.

Distribution

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

Key facts

Status

Completed

Initiation date

2018-12-20

Report date

2019-01-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Madison, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0387-2019