81 FDA recalls mention Dexamethasone. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Dexamethasone.
Reason Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were…
Reason Presence of particulate matter - Glass like particles.
Reason Presence of particulate matter - Glass like particles.
Reason Temperature Abuse
Reason 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…
Reason Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Reason cGMP deviations: Temperature abuse
Reason cGMP deviations: Temperature abuse
Reason Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
Reason CGMP Deviations
Reason Lack of Assurance of Sterility
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Lack of assurance of sterility: 13 vials were discovered to have faulty crimps.
Reason Lack of Assurance of Sterility
Reason Labeling: Incorrect or missing package insert.
Reason Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Reason Lack of Processing Controls
Reason CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Reason CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific…
Reason Lack of Assurance of Sterility
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