70 FDA recalls mention Hydrocortisone. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Hydrocortisone.
Reason CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the…
Reason CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the…
Reason CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the…
Reason CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the…
Reason CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the…
Reason Lack of Assurance of Sterility
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Reason Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.
Reason GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Reason CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of…
Reason CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of…
Reason CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of…
Reason Failed Stability Specifications
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Reason Incorrect Product Formulation: product contains dexamethasone instead of hydrocortisone.
Reason Superpotent Drug: above specification for the assay.
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 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.
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