Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Pine Pharmaceuticals
Lack of Assurance of Sterility
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Pine Pharmaceuticals
Lack of Assurance of Sterility
Pine Pharmaceuticals
Lack of Assurance of Sterility
CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
Lack of Assurance of Sterility
Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Lack of Assurance of Sterility
Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
Pine Pharmaceuticals
Lack of Assurance of Sterility
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.
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: