Product: Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA  92618, NDC 0703-5140-01.
Reason for recall: Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Recall initiated: 20210210
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated