Reported Jan 16, 2019 · Completed

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

Allergan, PLC.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Allergan, PLC. · 5 Giralda Farms · Madison, NJ · 07940-1027

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

Lot codes and dates: E78689
exp. date 06/21/2019 E78726
exp. date 06/29/2019 E78729
exp. date 07/01/2019 E78894
exp. date 08/09/2019 E79157
exp. date 09/05/2019 E79233
exp. date 09/15/2019 E79366
exp. date 10/06/2019 E79891
exp. date 12/07/2019 E80122
exp. date 01/18/2020 E80216
exp. date 02/06/2020 E81080
exp. date 05/09/2020 E81083
exp. date 05/22/2020 E81273
exp. date 05/31/2020 E81344
exp. date 06/21/2020 E82526
exp. date 12/11/2020 E82638
exp. date 12/20/2020 E82738
exp. date 01/18/2021 E82741
exp. date 01/23/2021 E82847
exp. date 01/29/2021 E82852
exp. date 02/01/2021 E83029
exp. date 02/26/2021 E83364
exp. date 04/18/2021
Amount recalled: 133,716 Cartons

GMP Deviations: A silicone particulate was noted in Ozurdex.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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