36 FDA recalls mention Fluocinolone. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Fluocinolone.
Reason Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Reason Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Reason Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Reason Lack of Processing Control
Reason Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that…
Reason Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
Reason Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification…
Reason Subpotent Drug
Reason Subpotent Drug
Reason Subpotent Drug
Reason Chemical Contamination
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Reason Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Reason Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Reason Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Reason Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Reason Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Reason Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Reason Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
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