Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride
Subpotent Drug
411 recalls · Class II, newest first
Subpotent Drug
Failed Impurities/Degradation Specification.
Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list.
Lack of Sterility Assurance: Aseptic process simulation failure.
Failed Dissolution Specifications
Subpotent Drug and Failed Impurities/Degradation Specifications
Subpotent Drug and Failed Impurities/Degradation Specifications
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Failed Impurities/Degradation Specifications
Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.