90 FDA recalls mention Estriol. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Estriol.
Reason Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Reason Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Reason cGMP Deviations
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 Failed impurities/ degradation specifications: Out of specification for organic impurities.
Reason Lack of Processing Control
Reason Lack of Processing Control
Reason Lack of Processing Control
Reason Subpotent
Reason Subpotent Drug: Supplier indicated assay results did not meet specifications.
Reason Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Reason Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Reason Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Reason Failed Impurities/Degradation Specifications
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
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 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 cGMP Deviations: lack of quality assurance at the API manufacturer.
Reason cGMP Deviations: lack of quality assurance at the API manufacturer.
Reason cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Reason cGMP Deviations; lack of quality assurance.
Reason Lack of Processing Controls
Reason Penicillin Cross Contamination: potentially contaminated with penicillin
Reason Penicillin Cross Contamination: potentially contaminated with penicillin
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