Savannah Antibacterial Towelettes
CGMP Deviations
2,357 recalls · Class II, newest first
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
Subpotent Drug
Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil.
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Superpotent and Subpotent
Superpotent and Subpotent
Presence of Foreign Substance
cGMP deviations.
Presence of Particulate Matter.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Out of specification for dissolution.
Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules