Class II · Moderate risk
Adcetris 96 MG/100 ML NS IVPB
Lack of Assurance of Sterility
FDA Drug Recalls
14,806 recalls, newest first
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 III · Low risk
Testosterone Topical Solution 30mg of testosterone per pump…
Defective Container; actuator may improperly function and affect dose delivery.
Class II · Moderate risk
Robafen DM
CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class I · High risk
Hydromorphone HCl in 0.9% sodium chloride
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
Myorisan (isotretinoin capsules, USP)
Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.
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.
Class II · Moderate risk
Ritussin DM Double Strength
cGMP Deviations: Products may have microbial contamination.
Class II · Moderate risk
Preferred Plus Pharmacy Iron Elixir Ferrous Sulfate
cGMP Deviations: Products may have microbial contamination.
Class II · Moderate risk
Gericare Iron Supplement Elixir Ferrous Sulfate
cGMP Deviations: Products may have microbial contamination.
Class II · Moderate risk
Gericare Diocto Liquid Docusate Sodium Stool Softener
cGMP Deviations: Products may have microbial contamination.
Class II · Moderate risk
Ritussin DM Children & Adults
cGMP Deviations: Products may have microbial contamination.
Class II · Moderate risk
Diphenhydramine Oral Liquid Alcohol Free
cGMP Deviations: Products may have microbial contamination.
Class II · Moderate risk
Zileuton Extended-Release Tablets
Failed Dissolution Specifications: Out of specification result for dissolution.
Class II · Moderate risk
ZYFLO CR (zileuton)
Failed Dissolution Specifications: Out of specification result for dissolution.