Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Vials (NDC 0641-6146-01), packaged in 25 x 5 mL Vials per shelf pack (NDC 0641-6146-25), Rx Only, Manufactured by WEST-WARD, Eatontown, NJ 07724 USA.
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 |
|---|---|---|---|---|
| Dexamethasone Sodium Phosphate NDC 00641-6146 |
4 mg/mL | Injection Intra-Articular|intralesional|intramuscular|intravenous|soft Tissue |
Hikma Pharmaceuticals USA Inc. | Rx |
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, 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.
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.
Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.
Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point
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