Severity
Moderate
ModerateClass IICompleted
FDA Drug recall · Reported January 16, 2019
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
GMP Deviations: A silicone particulate was noted in Ozurdex.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Allergan, PLC. recalled OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic applicator con… - a moderate-severity action.
OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic applicator con… was recalled by Allergan, PLC. in January 16, 2019. Reason: GMP Deviations: A silicone particulate was noted in Ozurdex.. Check the official notice for the remedy. Verify recall #D-0387-2019 with the FDA Drug before acting.
The recall
Allergan, PLC. issued this moderate-severity FDA Drug recall-GMP Deviations: A silicone particulate was noted in Ozurdex..
- Moderate
- severity level
- Class II
- classification
- January 16, 2019
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0387-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0387-2019) was formally reported on January 16, 2019, with the manufacturer initiating the action on December 20, 2018. It is classified under Moderate severity (Class II), with a current status of Completed. Allergan, PLC. is listed as the recalling firm, operating out of Madison, NJ. Federal records list the affected scope as 133,716 Cartons.
The documented reason for this recall is: GMP Deviations: A silicone particulate was noted in Ozurdex. Distribution data in the federal record shows the product reached: Product was distributed to various accounts throughout the United States including VA and Government Accounts. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
133,716 Cartons
Related Recalls
6
0 from same agency
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
Reason for recall
GMP Deviations: A silicone particulate was noted in Ozurdex.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Completed |
| Recall number | D-0387-2019 |
| Date reported | January 16, 2019 |
| Date initiated | December 20, 2018 |
| Recalling firm | Allergan, PLC. |
| Firm location | Madison, NJ |
| Affected scope | 133,716 Cartons |
| Distribution | Product was distributed to various accounts throughout the United States including VA and Government Accounts |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0387-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Allergan, PLC.. Units affected: 133,716 Cartons.
Why was this product recalled? ▼
GMP Deviations: A silicone particulate was noted in Ozurdex.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 16, 2019. Severity: Moderate. Recall number: D-0387-2019.
Where was the recalled product distributed? ▼
Distribution: Product was distributed to various accounts throughout the United States including VA and Government Accounts.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0387-2019) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported January 16, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.