Recalls / Class II

Class IID-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)

Affected lot / code info

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.

Why it was recalled

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

Recalling firm

Firm

Ben Venue Laboratories Inc

Notification channel

Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Type

Voluntary: Firm initiated

Address

300 Northfield Rd, N/A, Bedford, Ohio 44146

Distribution

Quantity

226,010 vials

Distribution pattern

Nationwide and Puerto Rico.

Timeline

Recall initiated

2012-07-05

FDA classified

2012-11-01

Posted by FDA

2012-11-07

Terminated

2013-08-30

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-036-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.