# FDA recall D-0387-2019

> **Allergan, PLC.** · Class II · drug recall initiated 2018-12-20.

## 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.

## Distribution

Product was distributed to various accounts throughout the United States including VA and Government Accounts

## Key facts

- **Recall number:** D-0387-2019
- **Recalling firm:** Allergan, PLC.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2018-12-20
- **Report date:** 2019-01-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Madison, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0387-2019

## Citation

> AI Analytics. FDA recall D-0387-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0387-2019. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*