Hydromorphone HCl in 0.9% sodium chloride
Reason Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the product is sulfite free, however the product is produced with a raw material that contains sulfite
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Reason Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the product is sulfite free, however the product is produced with a raw material that contains sulfite
Reason Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.
Reason cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Reason cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Reason cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
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 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.