Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg/…
Reason Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
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Reason Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
Reason Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
Reason Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
Reason Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.
Reason cGMP Deviations: Products may have microbial contamination.
Reason cGMP Deviations: Products may have microbial contamination.
Reason cGMP Deviations: Products may have microbial contamination.
Reason cGMP Deviations: Products may have microbial contamination.
Reason cGMP Deviations: Products may have microbial contamination.
Reason cGMP Deviations: Products may have microbial contamination.
Reason cGMP Deviations: Products may have microbial contamination.
Reason cGMP Deviations: Products may have microbial contamination.
Reason Failed Dissolution Specifications: Out of specification result for dissolution.
Reason Failed Dissolution Specifications: Out of specification result for dissolution.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of Processing Controls.
Reason Lack of Processing Controls.
Reason Lack of Processing Controls.
Reason Lack of Processing Controls.
Reason Lack of Processing Controls.
Reason Lack of Processing Controls.
Reason Lack of Processing Controls.
Reason Lack of Processing Controls.
Reason Labeling: Incorrect Instructions; The product has been found to provide incorrect dosage information on its label due to a typographical error. The drug facts label incorrectly states children 6 to under 2 years of age, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or directed by physician. The label should state children 6 to under 12, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or as directed by physician. Additionally, the label does not advise consumers to consult a doctor for children under 2 years of age.