OZURDEX — Class II drug recall D-0387-2019
Completed recall by Allergan, PLC., reported 2019-01-16, distributed nationwide. GMP Deviations: A silicone particulate was noted in Ozurdex.
| Recall number | D-0387-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Allergan, PLC., Madison, NJ, United States |
| Recall initiated | 2018-12-20 |
| Classified | 2019-01-18 |
| Reported by FDA | 2019-01-16 |
| Distributed | Nationwide (US) |
| Quantity | 133,716 cartons |
| Reason classes | cgmp, specification failure |
| NDC | 00023-3348, 00023-3348-07, 00023-3348-08 |
| Expiration dates | 2019-06-21, 2019-06-29, 2019-07-01, 2019-08-09, 2019-09-05, 2019-09-15, 2019-10-06, 2019-12-07, 2020-01-18, 2020-02-06, 2020-05-09, 2020-05-22, 2020-05-31, 2020-06-21, 2020-12-11, 2020-12-20, 2021-01-18, 2021-01-23, 2021-01-29, 2021-02-01, 2021-02-26, 2021-04-18 |
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
Reason for recall
GMP Deviations: A silicone particulate was noted in Ozurdex.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0387-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.