Ozurdex Implant
FDA Recall NDC 0023-3348
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Ozurdex (NDC 0023-3348). A significant event, classified as Class II, was initiated on Dec 20, 2018 by Allergan, Inc.. The reported reason for this action was: "GMP Deviations: A silicone particulate was noted in Ozurdex."
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Completed
GMP Deviations: A silicone particulate was noted in Ozurdex.
Dec 20, 2018
Jan 16, 2019
133,716 Cartons
Recall Profile & Regulatory Data
Event ID
81855
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Allergan, PLC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to various accounts throughout the United States including VA and Government Accounts
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
Batch or Lot Expiration Information
Lot# 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
Affected Packages Involved in this Recall
0023-3348-07Product
0023-3348-08Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
