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Recall Observatory FDA recall evidence

Drug 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

D-0387-2019

December 20, 2018

Class II

Product summary

Firm
Allergan, PLC.
Event
Event 81855
Status
Completed
Classification
Class II
Quantity
133,716 Cartons
Official record key
drug-enforcement:D-0387-2019

Official wording

Reason: GMP Deviations: A silicone particulate was noted in Ozurdex.

Code information: 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

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

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    particulate
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    GMP Deviations