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: 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.

Code information: Lot # a) 31324653B, exp. date 03/2021; 31326066B, exp. date 11/2021; 31326428B, exp. date 02/2022; 31327949B, exp. date 10/2022; 31327995B, exp. date 10/2022; 31328031B, exp. date 11/2022; 31328217B, exp. date 12/2022; 31328325B, exp. date 12/2022; 31328425B, exp. date 07/2021; Lot # b) 31324480B, exp. date 02/2021; Lot # 31327396B, exp. date 08/2022

Distribution pattern: Product was distributed nationwide in the USA and Puerto Rico.