Class II · Moderate risk
Hydromorphone HCL and Bupivacaine HCL in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
FDA Drug Recalls
1,563 recalls, newest first
Class II · Moderate risk
Hydromorphone HCL 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
Fentanyl Citrate and Bupivacaine 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
Fentanyl Citrate 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
Bupivacaine HCl and Hydromorphone HCl 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
Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL and…
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL 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
Baclofen 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
Baclofen 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
Clonidine HCL/Hydromorphone HCL 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
Glutamine/Arginine/Carnitine 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
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 I · High risk
Milk of Magnesia USP
Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial Count.
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 III · Low risk
Lamivudine Tablets
Labeling: Incorrect or Missing Package Insert; an error in the Dosage Forms and Strengths section of the insert that incorrectly lists the tablet description coding for the tablets.
Class III · Low risk
minolira (minocycline hydrochloride)
Failed Dissolution Specifications:
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