Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride, 2 mL per syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-0190-1
IntegraDose Compounding Services
Subpotent Drug
Prescription and over-the-counter medications
IntegraDose Compounding Services
Subpotent Drug
Lack of Sterility Assurance: Aseptic process simulation failure.
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
The Procter & Gamble Company
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Presence of Particulate Matter; identified as glass
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Chemical contamination: presence of benzene
The Procter & Gamble Company
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
The Procter & Gamble Company
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
The Procter & Gamble Company
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
The Procter & Gamble Company
Chemical contamination: presence of benzene
Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
The Procter & Gamble Company
Chemical contamination: presence of benzene
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
The Procter & Gamble Company
Chemical contamination: presence of benzene
The Procter & Gamble Company
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene