Product: 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)
Reason for recall: Presence of Particulate Matter: visible crystalline particulates and the discovery of crystalline particulate in a retain sample.
Recall initiated: 20120705
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated