FDA recall D-036-2013

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.

Distribution

Nationwide and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2012-07-05

Report date

2012-11-07

Termination date

2013-08-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bedford, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-036-2013