Trypan Blue 0.3%, 0.5 mL Vial, Vital Care Compounder, Hattiesburg, MS
Vital Care Compounder
Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.
Prescription and over-the-counter medications
Vital Care Compounder
Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.
Vital Care Compounder
Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.
Dr. Reddy's Laboratories
Failed impurities/degradation specification: An out of specification results has been determined for an individual related substance during stability testing at the 18th month interval for the Famotidine 10 mg Tablet, USP.
CGMP Deviations
Vital Care Compounder
Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.
Aidarex Pharmaceuticals
Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.
Valeant Pharmaceuticals North America
Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis.
Discoloration: presence of scuffing marks on tablets.
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Attix Pharmaceuticals
cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration
Virtus Pharmaceuticals
Chemical Contamination: Bottles may contain broken dessicants
Profarma Distributors
CGMP Deviations
Profarma Distributors
CGMP Deviations
Profarma Distributors
CGMP Deviations
Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on the immediate container.
Profarma Distributors
CGMP Deviations
Profarma Distributors
CGMP Deviations
Virtus Pharmaceuticals
Defective delivery system: Softgel capsules are leaking.
Labeling: Incorrect or Missing Package Insert