Ganciclovir for Injection
Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
11,818 recalls · Class II, newest first
Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
cGMP Deviations
cGMP Deviations
cGMP Deviations
cGMP Deviations
cGMP Deviations
Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.
cGMP Deviations
cGMP Deviations
cGMP Deviations
cGMP Deviations
Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.
Presence of foreign substance
Underfilled units.
Lack of sterility assurance: Bags have the potential to leak.
Subpotent Drug
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.