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)

FDA recall notice · announced November 7, 2012 · Ben Venue Laboratories

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

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

Notes

Distribution: Nationwide and Puerto Rico.
Lot/code information: Lot #, 2017619 (Bedford), Mfr Item # 0967-57-2017619, NDC, 55390-009-01, Exp. Date 11/2012; Lot# 2017620, Exp. Date 1/2013, NDC #55390-009-01; Lot #, 2017621 (Bedford), Mfr Item # 0967-57-2017621, NDC, 55390-009-01, Exp Date 01/2013; Lot #2038374, exp. 2/2013, NDC #55390-009-01; Lot #2038374A, exp. 2/2013, NDC #55390-826-01 Note: 2038374A (packaged using Novaplus labeling) is a sublot of 2038374 (packaged using Bedford labeling); Lot #, 2038375 (Bedford), Mfr Item # 0967-57-2038375, NDC, 55390-009-01, Exp Date 03/2013; Lot #, 2065418 (Bedford), Mfr Item # 0967-57-2065418, NDC, 55390-009-01, Exp Date 06/2013; Lot #, 2067176 (Bedford), Mfr Item # 0967-57-2067176, NDC, 55390-009-01, Exp Date, 06/2013; Lot #, 2067177 (Bedford), Mfr Item # 0967-57-2067177, NDC, 55390-009-01, Exp Date 06/2013 & Lot #, 2067178A (Novaplus), Mfr Item # 0967-57-2067178A, NDC, 55390-826-01, Exp Date, 06/2013.
Quantity: 226,010 vials
Status: Terminated
Products in this recall event:
- 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) (D-036-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.