Class II · Moderate risk Terminated
Cetuximab 335 Mg / 167.5 Ml Ivpb
Reason Lack of Assurance of Sterility
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
Carfilzomib 65 Mg in 50 Ml D5w Ivpb
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
CARBOPLATIN 174 MG / 250ml NS IVPB
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Calcium Gluconate 1 Gm /100 Ml Nacl 0.9% Ivpb
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
BORTEZOMIB 2.5 mg / 1 ML SQ SYRINGE
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Bleomycin 18 Units / 100 Ml Ns Ivpb
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Bevacizumab 784 Mg / 100 Ml Ns Ivpb
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Azacitidine 125 Mg / 5 Ml Sub-Q Syringe
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Avastin 630 Mg / 100 Ml 0.9% Nacl Ivpb
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Atezolizumab 1200 Mg / 250 Ml 0.9% Nacl
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
ALIMTA 785 mg QS 100 ml 0.9% NACL IVPB
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
ADO-TRASTUZUMAB 210 MG/250 ml NS
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Adcetris 96 MG/100 ML NS IVPB
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Abraxane 170 MG / 34 ML IVPB
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Oxytocin 60 units/1000 mL Lactated Ringers Intravenous Solution
Reason Lack of Assurance of Sterility
Class III · Low risk Terminated
Testosterone Topical Solution 30mg of testosterone per pump…
Reason Defective Container; actuator may improperly function and affect dose delivery.
Class II · Moderate risk Terminated
Robafen DM
Reason CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class I · High risk Terminated
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
Class III · Low risk Terminated
Myorisan
Reason Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.
Class II · Moderate risk Ongoing
LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles
Reason CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Class II · Moderate risk Ongoing
LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles
Reason CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Class II · Moderate risk Terminated
Cetirizine Oral Solution 1 mg/mL
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).
Class II · Moderate risk Terminated
Cetirizine Oral Solution 1 mg/mL
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).
Class II · Moderate risk Terminated
Cetirizine HCL Oral Solution 1 mg/mL
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).
Class II · Moderate risk Terminated
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