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; deficiencies observed during FDA inspection
Reason CGMP Deviations; deficiencies observed during FDA inspection
Reason Subpotent Drug
Reason Subpotent Drug
Reason Subpotent Drug
Reason CGMP Deviations
Reason Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established…
Reason Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established…
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason Lack of sterility assurance
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Reason cGMP deviations: Temperature abuse
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Reason cGMP deficiencies
Reason CGMP Deviations
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason SUBPOTENT DRUG
Reason Lack of Processing Control
Reason Lack of Processing Control
Reason Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
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