FDA-Drug2019-01-16Class II
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
Allergan, PLC.
Hazard
GMP Deviations: A silicone particulate was noted in Ozurdex.
Sold states
Product was distributed to various accounts throughout the United States including VA and Government Accounts
Affected count
133,716 Cartons
Manufactured in
5 Giralda Farms, Madison, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0387-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief