Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Pine Pharmaceuticals
Lack of Assurance of Sterility
Prescription and over-the-counter medications
Pine Pharmaceuticals
Lack of Assurance of Sterility
Failed Dissolution Specifications
Pine Pharmaceuticals
Lack of Assurance of Sterility
Pine Pharmaceuticals
Lack of Assurance of Sterility
Pine Pharmaceuticals
Lack of Assurance of Sterility
Pine Pharmaceuticals
Lack of Assurance of Sterility
Pine Pharmaceuticals
Lack of Assurance of Sterility
Pine Pharmaceuticals
Lack of Assurance of Sterility
Pine Pharmaceuticals
Lack of Assurance of Sterility
Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
Dollar Tree Distribution
CGMP Deviations: OTC products were stored outside of labeled temperature requirements.
Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial beta-lactam compound).
Central Admixture Pharmacy Services
Lack of assurance of sterility:
Central Admixture Pharmacy Services
Lack of assurance of sterility:
Central Admixture Pharmacy Services
Lack of assurance of sterility:
Central Admixture Pharmacy Services
Lack of assurance of sterility:
Central Admixture Pharmacy Services
Lack of assurance of sterility:
Dr. Berne's Whole Health Products
CGMP Deviations
Central Admixture Pharmacy Services
Lack of assurance of sterility:
Central Admixture Pharmacy Services
Lack of assurance of sterility: