December 2018 FDA Recall Ozurdex by Allergan, Plc.
D-0387-2019 - GMP Deviations
This Class II drug recall was voluntarily initiated by Allergan, Plc. on December 20, 2018 for the product Ozurdex. The FDA reported the reason for recall as gmp deviations. The product was distributed in Product was distributed to various accounts throughout the United States including VA and Government Accounts and the recall is currently completed.
Recall Number: D-0387-2019
GMP Deviations: A silicone particulate was noted in Ozurdex.
12-20-2018
01-16-2019
133,716 Cartons
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Allergan, PLC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to various accounts throughout the United States including VA and Government Accounts
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
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
