Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
GMP Deviations: A silicone particulate was noted in Ozurdex.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
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
Compare with the code on your package — it is the most precise check available.
Drug: Dexamethasone
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Ozurdex dexamethasone NDC 00023-3348 |
.7 mg/1 | Implant Intravitreal |
Allergan, Inc. | Rx |
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now completed, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.
Presence of particulate matter - Glass like particles.
Presence of particulate matter - Glass like particles.
Temperature Abuse
Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the outer box on some of the Dexonto 0.4% are labeled incorrectly with a BUD of 12/25/2025.
Labeling: Missing instructions for use insert
SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
Failed Stability Specification: out of specification for iron content.
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