Class II · Moderate risk Terminated
Glutamine/Arginine/Carnitine in all strengths
Reason Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Clonidine HCL and Morphine Sulfate in all strengths
Reason Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk Terminated
Bevacizumab
Reason Lack of assurance of sterility.
Class II · Moderate risk Terminated
Bevacizumab
Reason Lack of assurance of sterility.
Class II · Moderate risk Terminated
Oxaliplatin Active Pharmaceutical Ingredient
Reason cGMP Deviations: Potential glass contamination
Class II · Moderate risk Terminated
Cisplatin Active Pharmaceutical Ingredient
Reason cGMP Deviations: Potential glass contamination
Class II · Moderate risk Terminated
Fentanyl Citrate Active Pharmaceutical Ingredient
Reason cGMP Deviations: Potential glass contamination
Class II · Moderate risk Terminated
Fexofenadine HCl Tablets
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg
Reason Failed Stability Specifications.
Class II · Moderate risk Terminated
Ascorbic Acid Sterile Injection Solution
Reason Labeling: Not Elsewhere Classified; product is labeled as "Non-Corn Source" however the product is from a corn source.
Class II · Moderate risk Terminated
Entropic Labs SARM RAD-140
Reason Marketed Without An Approved NDA/ANDA: product contains Selective Androgen Receptor Modulators (SARMs)
Class II · Moderate risk Terminated
Allergy
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Wal-Fex
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Allergy
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Fexofenadine HCL Tablets USP
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Fexofenadine Hydrochloride Tablets USP
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Allergy Relief
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Fexofenadine Hydrochloride Tablets USP
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
fexofenadine hydrochloride tablets USP
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Allergy Relief
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Allergy Relief
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Fexofenadine Hydrochrloride Tablets USP
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Relpax
Reason Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.
Class II · Moderate risk Terminated
S-TRIMIX various strengths to include:a) S-TRIMIX
Reason Lack of Assurance of Sterility