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
Check against the official notice below — it lists the full affected range.
Allergan is recalling Ozurdex (dexamethasone intravitreal implant) 0.7 mg across multiple lot codes due to the presence of a silicone particulate found in the product. The affected lots were distributed throughout the United States, including to various accounts in Virginia and government accounts, with expiration dates ranging from June 2019 through April 2021. A total of 133,716 cartons are involved in this recall related to manufacturing practice deviations.
The source document does not specify a remedy or instructions for affected consumers regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
GMP Deviations: A silicone particulate was noted in Ozurdex.
Reason for recall: GMP Deviations: A silicone particulate was noted in Ozurdex. Distribution: Product was distributed to various accounts throughout the United States including VA and Government Accounts Quantity: 133,716 Cartons Lot/code info: 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
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.