SENNA Syrup
Microbial Contamination of Non-Sterile Product
124 recalls · Class I, newest first
Microbial Contamination of Non-Sterile Product
Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.
Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Superpotent Drug
Chemical contamination: presence of benzene
Chemical contamination: presence of benzene
Chemical contamination: presence of benzene
Chemical contamination: presence of benzene
Chemical contamination: presence of benzene
Chemical contamination: presence of benzene
Chemical contamination: presence of benzene
Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
Temperature Abuse; temperature excursion during shipping
Chemical contamination: Presence of benzene
Chemical Contamination: presence of benzene, acetaldehyde, and acetal.
Presence of Particulate Matter: Identified as Glass Particles
Superpotent Drug
Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets
Chemical Contamination: presence of benzene
Chemical Contamination: presence of benzene
Chemical Contamination: presence of benzene
Chemical Contamination: presence of benzene
Chemical Contamination: presence of benzene