Allergan, PLC. recalls OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic applicator contained within carton, Rx only,
Recalled January 16, 2019 · FDA recall D-0387-2019 · Allergan
Hazard
GMP Deviations: A silicone particulate was noted in Ozurdex. · FDA Class II
Units
133,716 Cartons
Sold at
Product was distributed to various accounts throughout the United States including VA and Government Accounts
Description
GMP Deviations: A silicone particulate was noted in Ozurdex.
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
Manufacturer(s)
Allergan, PLC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →