Class II · Moderate risk
Glutamine/Arginine/Carnitine in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
FDA Drug Recalls
1,586 recalls · Class II, newest first
Class II · Moderate risk
Clonidine HCL and Morphine Sulfate in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Bevacizumab
Lack of assurance of sterility.
Class II · Moderate risk
Bevacizumab
Lack of assurance of sterility.
Class II · Moderate risk
Oxaliplatin Active Pharmaceutical Ingredient
cGMP Deviations: Potential glass contamination
Class II · Moderate risk
Cisplatin Active Pharmaceutical Ingredient
cGMP Deviations: Potential glass contamination
Class II · Moderate risk
Fentanyl Citrate Active Pharmaceutical Ingredient
cGMP Deviations: Potential glass contamination
Class II · Moderate risk
Fexofenadine HCl Tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg
Failed Stability Specifications.
Class II · Moderate risk
Ascorbic Acid Sterile Injection Solution
Labeling: Not Elsewhere Classified; product is labeled as "Non-Corn Source" however the product is from a corn source.
Class II · Moderate risk
Entropic Labs SARM RAD-140
Marketed Without An Approved NDA/ANDA: product contains Selective Androgen Receptor Modulators (SARMs)
Class II · Moderate risk
Allergy (Fexofenadine Hydrochloride)
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Wal-Fex (Fexofenadine Hydrochloride)
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Allergy (Fexofenadine Hydrochloride)
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Fexofenadine HCL Tablets USP
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Fexofenadine Hydrochloride Tablets USP
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Allergy Relief
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Fexofenadine Hydrochloride Tablets USP
Failed Impurities/Degradation Specifications
Class II · Moderate risk
fexofenadine hydrochloride tablets USP
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Allergy Relief
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Allergy Relief
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Fexofenadine Hydrochrloride Tablets USP
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use
Lack of Assurance of Sterility.
Class II · Moderate risk
RELPAX (eletriptan HBr)
Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.
Class II · Moderate risk
S-TRIMIX various strengths to include:a) S-TRIMIX
Lack of Assurance of Sterility