Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-5140-01.

Recall Number: D-0276-2021

Firm: Teva Pharmaceuticals USA

Classification: Class II

Status: Terminated

Report Date: 20210303

Initiation Date: 20210210

Termination Date: 20240515

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.

Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-5140-01.