Class II · Moderate risk
Calcium Gluconate 1 Gm /100 Ml Nacl 0.9% Ivpb
Lack of Assurance of Sterility
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
Class II · Moderate risk
BORTEZOMIB 2.5 mg / 1 ML SQ SYRINGE
Lack of Assurance of Sterility
Class II · Moderate risk
Bleomycin 18 Units / 100 Ml Ns Ivpb
Lack of Assurance of Sterility
Class II · Moderate risk
Bevacizumab 784 Mg / 100 Ml Ns Ivpb
Lack of Assurance of Sterility
Class II · Moderate risk
Azacitidine 125 Mg / 5 Ml Sub-Q Syringe
Lack of Assurance of Sterility
Class II · Moderate risk
Avastin 630 Mg / 100 Ml 0.9% Nacl Ivpb
Lack of Assurance of Sterility
Class II · Moderate risk
Atezolizumab 1200 Mg / 250 Ml 0.9% Nacl
Lack of Assurance of Sterility
Class II · Moderate risk
ALIMTA 785 mg QS 100 ml 0.9% NACL IVPB
Lack of Assurance of Sterility
Class II · Moderate risk
ADO-TRASTUZUMAB 210 MG/250 ml NS
Lack of Assurance of Sterility
Class II · Moderate risk
Adcetris 96 MG/100 ML NS IVPB
Lack of Assurance of Sterility
Class II · Moderate risk
Abraxane 170 MG / 34 ML IVPB
Lack of Assurance of Sterility
Class II · Moderate risk
Oxytocin 60 units/1000 mL Lactated Ringers Intravenous Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Robafen DM
CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles
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
LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles
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
Cetirizine Oral Solution 1 mg/mL
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
Cetirizine Oral Solution 1 mg/mL
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
Cetirizine HCL Oral Solution 1 mg/mL
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
Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg
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
Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg/ Extended-Release Tablets
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
Allergy Relief D
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
Allergy Relief D
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
Estradiol Vaginal Inserts USP 10 mcg
Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.
Class II · Moderate risk
Preferred Plus Dioctyl Liquid Stool Softener
cGMP Deviations: Products may have microbial contamination.
Class II · Moderate risk
Gericare Geri-Tussin DM
cGMP Deviations: Products may have microbial contamination.