Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50 Rx Only Ingenus Pharmaceuticals, LLC. Orlando, FL 32839

Recall Number: D-0146-2020

Firm: Ingenus Pharmaceuticals Llc

Classification: Class II

Status: Terminated

Report Date: 20191023

Initiation Date: 20191009

Termination Date: 20201201

Crystallization: Presence of particulate matter identified as API crystallization

Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50 Rx Only Ingenus Pharmaceuticals, LLC. Orlando, FL 32839