Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-002-58

Recall Number: D-0014-2025

Firm: Fresenius Kabi Compounding, LLC

Classification: Class II

Status: Terminated

Report Date: 20241030

Initiation Date: 20240925

Termination Date: 20250815

CGMP violations

Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-002-58