Leucovorin Calcium Injection USP, single use vials, 10mg/mL; 50mL, Rx only, Manufactured by: Ben Venue Labs, Inc., Bedford, OH 44146, NDC# 55390-009-01(Bedford); NDC# 55390-826-01(Novaplus)

Recall Number: D-036-2013

Firm: Ben Venue Laboratories Inc

Classification: Class II

Status: Terminated

Report Date: 20121107

Initiation Date: 20120705

Termination Date: 20130830

Presence of Particulate Matter: visible crystalline particulates and the discovery of crystalline particulate in a retain sample.

Leucovorin Calcium Injection USP, single use vials, 10mg/mL; 50mL, Rx only, Manufactured by: Ben Venue Labs, Inc., Bedford, OH 44146, NDC# 55390-009-01(Bedford); NDC# 55390-826-01(Novaplus)