Class I - Dangerous
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
Bayer HealthCare Pharmaceuticals
Chemical Contamination: presence of benzene
Chemical Contamination: presence of benzene
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Chemical Contamination: presence of benzene
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Chemical Contamination: presence of benzene
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Chemical Contamination: presence of benzene
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Chemical Contamination: presence of benzene
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facility where other lots were found to be contaminated with benzene.
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Chemical Contamination: presence of benzene
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Chemical Contamination: presence of benzene
Labeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange Bayer logo located on the lower left corner of the front of the carton, because the ingredients on the front sticker may not match the actual product in the carton.
Labeling: Label mix-up
Class I - Dangerous
Failed Stability Specifications
Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue.
Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.
Class I - Dangerous
Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point.
Class I - Dangerous
Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross contamination with another product.