Class I · High risk Terminated
The Medical Center of Aurora
Reason Non-Sterility: Out of specification results for the sterility test for microbial contamination.
FDA Drug Recalls
1,739 recalls · Class I, newest first
Class I · High risk Terminated
Rose Medical Center
Reason Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk Terminated
Rose Medical Center
Reason Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk Terminated
Children's Hospital Colorado Springs TPN Neonate Starter Bag 4% AA/10% DEX
Reason Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk Terminated
University of Alabama Birmingham TPN Neonatal Starter Bag
Reason Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk Terminated
Professional Formexx Black
Reason Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Class I · High risk Terminated
Swoll-250 Super Mass Builder Quad Stack
Reason Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Class I · High risk Terminated
Estrastain Pro-Anabolic Mass and Hardening Complex
Reason Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Class I · High risk Terminated
7-Ment Alpha Advanced Mass Builder
Reason Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Class I · High risk Terminated
Halo-70 Mega Mass Builder
Reason Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Class I · High risk Terminated
M14-Ment Advanced Mass Builder
Reason Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Class I · High risk Terminated
M1-Alpha Labs Mega Mass Builder
Reason Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Class I · High risk Terminated
0.9% Sodium Chloride Injection USP
Reason Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.
Class I · High risk Terminated
MitoXANTRONE Injection
Reason Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.
Class I · High risk Terminated
Forever Beautiful BEE POLLEN
Reason Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phenolphthalein
Class I · High risk Terminated
Forever Beautiful INFINITY
Reason Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phenolphthalein
Class I · High risk Terminated
1% LIDOCAINE HCl Injection
Reason Presence of particulate matter: A returned customer sample was evaluated and found to have human hair attached to a pinched area of the stopper.
Class I · High risk Terminated
Propofol Injectable Emulsion
Reason Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Class I · High risk Terminated
Heparin Sodium
Reason Presence of Particulate Matter: A particulate, confirmed as human hair, was found sealed between the tube and film at the round seal of the unused administrative port of the container.
Class I · High risk Terminated
Tropi/Cyclo/Phenyl/Tobra/Flurb
Reason Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
Class I · High risk Terminated
Magnesium Chloride 20%
Reason Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
Class I · High risk Terminated
Glutathione 100mg/mL Sterile Injection
Reason Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
Class I · High risk Terminated
Ascorbic Acid 500 mg/mL Sterile Injection
Reason Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
Class I · High risk Terminated
Cubicin
Reason Presence of Particulate Matter: Foreign particulate matter (tiny black specs) were observed at the bottom of the vial following reconstitution.
Class I · High risk Terminated
Dianeal Low Calcium
Reason Presence of Particulate Matter: particulate matter was found during the manufacturing process.