Class II · Moderate risk Terminated
Azacitidine 125 Mg / 5 Ml Sub-Q Syringe
Reason Lack of Assurance of Sterility
FDA Drug Recalls
11,815 recalls · Class II, newest first
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 II · Moderate risk Terminated
Robafen DM
Reason CGMP Deviations: Potential product 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 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
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
Class II · Moderate risk Terminated
Allergy Relief D
Reason Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
Class II · Moderate risk Terminated
Allergy Relief D
Reason Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
Class II · Moderate risk Terminated
Estradiol Vaginal Inserts USP 10 mcg
Reason Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.
Class II · Moderate risk Terminated
Preferred Plus Dioctyl Liquid Stool Softener
Reason cGMP Deviations: Products may have microbial contamination.
Class II · Moderate risk Terminated
Gericare Geri-Tussin DM
Reason cGMP Deviations: Products may have microbial contamination.
Class II · Moderate risk Terminated
Ritussin DM Double Strength
Reason cGMP Deviations: Products may have microbial contamination.
Class II · Moderate risk Terminated
Preferred Plus Pharmacy Iron Elixir Ferrous Sulfate
Reason cGMP Deviations: Products may have microbial contamination.
Class II · Moderate risk Terminated
Gericare Iron Supplement Elixir Ferrous Sulfate
Reason cGMP Deviations: Products may have microbial contamination.
Class II · Moderate risk Terminated
Gericare Diocto Liquid Docusate Sodium Stool Softener
Reason cGMP Deviations: Products may have microbial contamination.
Class II · Moderate risk Terminated
Ritussin DM Children & Adults
Reason cGMP Deviations: Products may have microbial contamination.
Class II · Moderate risk Terminated
Diphenhydramine Oral Liquid Alcohol Free
Reason cGMP Deviations: Products may have microbial contamination.