Product: Leucovorin Calcium for Injection, USP, 350 mg/vial, Rx only, labeled as a) Teva Parenteral Medicines, Inc., Irvine, CA  92618, and b) Manufactured By: Teva Pharmaceuticals USA, Inc., North Wales, PA  19454, novaplus+, NDC 0703-5145-01.
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