OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic applicator contained w...
FDA Recall #D-0387-2019 — Class II — December 20, 2018
Product Description
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.
Recalling Firm
Allergan, PLC. — Madison, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
133,716 Cartons
Distribution
Product was distributed to various accounts throughout the United States including VA and Government Accounts
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
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated